Publications About NICEATM and ICCVAM Activities in Scientific Journals

Bishop PL, Mansouri K, Eckel WP, Lowit MB, Allen D, Blankinship A, Lowit AB, Harwood DE, Johnson T, Kleinstreuer NC. 2024. Evaluation of in silico model predictions for mammalian acute oral toxicity and regulatory application in pesticide hazard and risk assessment. Reg Toxicol Pharmacol 149:105614. https://doi.org/10.1016/j.yrtph.2024.105614.

Debad SJ, Aungst J, Carstens K, Ferrer M, Fitzpatrick S, Fritsche E, Geng Y, Hartung T, Hogberg HT, Li R, Mangas I, Marty S, Musser S, Perron M, Rattan S, Rüegg J, Sachana M, Schenke M, Shafer TJ, Smirnova L, Talpos J, Tanguay RL, Terron A, Bandele O. 2024. State of the science on assessing developmental neurotoxicity using new approach methods. ALTEX. https://doi.org/10.14573/altex.2410231. 

Fleming JF, House JS, Chappel JR, Motsinger-Reif AA, Reif DM. 2024. Guided optimization of ToxPi model weights using a semi-automated approach. Comput Toxicol 29:100294. https://doi.org/10.1016/j.comtox.2023.100294.

Foster C, Wignall J, Kovatch S, Choksi N, Allen D, Trgovcich J, Rochester JR, Ceger P, Daniel A, Hamm J, Truax J, Blake B, McIntyre B, Sutherland V, Stout MD, Kleinstreuer N. 2024. Standardizing extracted data using automated application of controlled vocabularies. Environ Health Perspect 132(2):027006. https://doi.org/10.1289/EHP13215.

Herzler M, Abedini J, Allen DG, Germolec D, Gordon J, Ko HS, Matheson J, Reinke I, Strickland J, Thierse HJ, To K, Truax J, Vanselow JT, Kleinstreuer N. 2024. Use of human predictive patch test (HPPT) data for the classification of skin sensitization hazard and potency. Arch Toxicol 98:1253-1269. https://doi.org/10.1007/s00204-023-03656-4.

Hogberg HT, Tsaioun K, Breidenbach JD, Elmore B, Filipovska J, Garcia-Reyero N, Hargreaves AJ, Joshi O, Omeragic E, Plant S, Ram R, Virmani I, Waspe J, Macmillan DS. 2024. A systematic scoping review of the neurological effects of COVID-19. NeuroToxicology 103:16-26. https://doi.org/10.1016/j.neuro.2024.05.003.

Kleinstreuer N, Hartung T. 2024. Artificial intelligence (AI) – it's the end of the tox as we know it (and I feel fine)*. Arch Toxicol 98:735-754. https://link.springer.com/article/10.1007/s00204-023-03666-2.

Kreutz A, Chang X, Hogberg HT, Wetmore BA. 2024. Advancing understanding of human variability through toxicokinetic modeling, in vitro-in vivo extrapolation, and new approach methodologies. Hum Genomics. https://doi.org/10.1186/s40246-024-00691-9.

Kreutz A, Oyetade OB, Chang X, Hsieh JH, Behl M, Allen DG, Kleinstreuer NC, Hogberg HT. 2024. Integrated approach for testing and assessment for developmental neurotoxicity (DNT) to prioritize aromatic organophosphorus flame retardants. Toxics 12(6):437. https://doi.org/10.3390/toxics12060437.

Mansouri K, Moreira-Filho JT, Lowe CN, Charest N, Martin T, Tkachenko V, Judson R, Conway M, Kleinstreuer NC, Williams AJ. 2024. Free and open-source QSAR-ready workflow for automated standardization of chemical structures in support of QSAR modeling. J Cheminform 16:19. https://doi.org/10.1186/s13321-024-00814-3.

Mansouri K, Taylor K, Auerbach S, Ferguson S, Frawley R, Hsieh JH, Jahnke G, Kleinstreuer N, Mehta S, Moreira-Filho JT, Parham F, Rider C, Rooney AA, Wang A, Sutherland V. 2024. Unlocking the potential of clustering and classification approaches: navigating supervised and unsupervised chemical similarity. Environ Health Perspect 132(8):085002. https://doi.org/10.1289/EHP14001.

Raabe HA, Costin GE, Allen DG, Lowit A, Corvaro M, O'Dell L, Breeden-Alemi J, Page K, Perron M, Flint Silva T, Westerink W, Baker E, Sullivan K. 2024. Human relevance of in vivo and in vitro skin irritation tests for hazard classification of pesticides. Cut Ocular Toxicol. https://doi.org/10.1080/15569527.2024.2387596.

Reinke EN, Reynolds J, Gilmour N, Reynolds G, Strickland J, Germolec D, Allen DG, Maxwell G, Kleinstreuer NC. 2024. The skin allergy risk assessment-integrated chemical environment (SARA-ICE) defined approach to derive points of departure for skin sensitization. Current Research in Toxicology. https://doi.org/10.1016/j.crtox.2024.100205.

Sakamuru S, Ma D, Pierro JD, Baker NC, Kleinstreuer N, Cali JJ, Knudsen TB, Xia M. 2024. Development and validation of CYP26A1 inhibition assay for high-throughput screening. Biotechnology Journal 19(6):2300659. https://doi.org/10.1002/biot.202300659.

Scheufen Tieghi R, Moreira-Filho JT, Martin HJ, Wellnitz J, Camamary Otoch M, Rath M, Tropsha A, Muratov EN, Kleinstreuer N. 2024. A novel machine learning model and a web portal for predicting the human skin sensitization effects of chemical agents. Toxics 12(11):803. https://doi.org/10.3390/toxics12110803.

Sharma M, Huber E, Arnesdotter E, Behrsing HP, Bettmann A, Brandwein D, Constant S, Date R, Deshpande A, Fabian E, Gupta A, Gutierrez R, Gutleb AC, Hargrove MM, Hollings M, Hutter V, Jarabek AM, Kaluzhny Y, Landsiedel R, Milchak L, Moyer RA, Murray JR, Page K, Patel M, Pearson SN, Petersen EJ, Reinke E, Roldan N, Roper C, Scaglione JB, Settivari RS, Stucki AO, Verstraelen S, Wallace JL, McCullough S, Clippinger AJ. 2024. Minimum information for reporting on the TEER (trans-epithelial/endothelial electrical resistance) assay (MIRTA). Arch Toxicol. https://doi.org/10.1007/s00204-024-03879-z.

Smirnova L, Hogberg HT, Leist M, Hartung T. 2024. Revolutionizing developmental neurotoxicity testing – a journey from animal models to advanced in vitro systems. ALTEX 41(2):152-178. https://doi.org/10.14573/altex.2403281.

Stratford K, Kang JC, Healy SM, Tu A, Valerio LG. 2024. Investigative analysis of blood-brain barrier penetrating potential of electronic nicotine delivery systems (e-cigarettes) chemicals using predictive computational models. Expert Opin Drug Metab Toxicol 20(7):647-663. https://doi.org/10.1080/17425255.2024.2366385.

Stucki AO, Sauer UG, Allen DG, Kleinstreuer NC, Perron MM, Yozzo KL, Lowit AB, Clippinger AJ. 2024. Differences in the anatomy and physiology of the human and rat respiratory tracts and impact on toxicological assessments. Reg Toxicol Pharmacol 150:105648. https://doi.org/10.1016/j.yrtph.2024.105648.

To KT, Strickland J, Reinke E, Borrel A, Truax J, Maldonado H, Allen D, Kleinstreuer N. 2024. Computational application of internationally harmonized defined approaches to skin sensitization: DASS App. BMC Bioinformatics 25:4. https://doi.org/10.1186/s12859-023-05617-1.

Bishop PL, Brescia S, Brunner R, Casey W, Conlee-Griffin K, Currie RA, Domoradzki J, Embry M, Harris MI, Hartung T, Hilton GM, Hooberman B, Ingle B, Jang KJ, Kinter L, Krall C, Leedale J, Lowit A, Mehta J, Mendez E, Mingoia B, Munarriz E, Murphy L, Myer A, Ottoni A, Panzarea M, Perron M, Pina J, Ramsingh D, Sewell F, Swanson J, Tan YM, Terron A, Trainer MA, Valadares MC, Webb S, Webb E, Willett C, Wolf DC. 2023. Challenges and opportunities for overcoming dog use in agrochemical evaluation and registration. ALTEX 40(3):534-540. https://doi.org/10.14573/altex.2302151.

Borrel A, Conway M, Nolte SZ, Unnikrishnan A, Schmitt CP, Kleinstreuer NC. 2023. ChemMaps.com v2.0: exploring the environmental chemical universe. Nucleic Acids Res 51(W1):W78-W82. https://doi.org/10.1093/nar/gkad380.

Ceger P, Allen D, Blankinship A, Choksi N, Daniel A, Eckel WP, Hamm J, Harwood DE, Johnson T, Kleinstreuer N, Sprankle CS, Truax J, Lowit M. 2023. Evaluation of the fish acute toxicity test for pesticide registration. Reg Toxicol Pharmacol 139:105340. https://doi.org/10.1016/j.yrtph.2023.105340.

Flannery BM, Turley AE, Anyangwe N, Mattia A, Whiteside C, Hermansky S, Schaefer HR, Tyler T, Fitzpatrick SC. 2023. Retrospective analysis of dog study data from food and color additive petitions. Reg Toxicol Pharmacol 145:105523. https://doi.org/10.1016/j.yrtph.2023.105523.

Golden E, Allen D, Amberg A, Anger LT, Baker E, Baran S, Bringezu F, Clark M, Duchateau-Nguyen G, Escher SE, Giri V, Grevot A, Hartung T, Li D, Lotfi L, Muster W, Snyder K, Wange R, Steger-Hartmann T. 2023. Toward implementing virtual control groups in nonclinical safety studies: workshop report and roadmap to implementation. ALTEX. https://doi.org/10.14573/altex.2310041.

Hsieh JH, Nolte S, Hamm JT, Wang Z, Roberts GK, Schmitt CP, Ryan KR. 2023. Systematic Evaluation of the Application of Zebrafish in Toxicology (SEAZIT): Developing a data analysis pipeline for the assessment of developmental toxicity with an interlaboratory study. Toxics. 11(5):407. https://doi.org/10.3390/toxics11050407.

Jordan R, Ford-Scheimer SL, Alarcon RM, Atala A, Borenstein JT, Brimacombe KR, Cherry S, Clevers H, Davis MI, Funnell SGP, Gehrke L, Griffith LG, Grossman AC, Hartung T, Ingber DE, Kleinstreuer NC, Kuo CJ, Lee EM, Mummery CL, Pickett TC, Ramani S, Rosado-Olivieri EA, Struble EB, Wan Z, Williams MS, Hall MD, Ferrer M, Markossian S. 2023. Report of the Assay Guidance Workshop on 3-Dimensional Tissue Models for Antiviral Drug Development. J Inf Diseases 228(Suppl 5):S337-S354. https://doi.org/10.1093/infdis/jiad334.

Kleinstreuer NC, Allen D. 2023. Novel approaches and alternative models: Validation and regulatory acceptance of toxicological testing methods and strategies. In: Hayes' Principles and Methods of Toxicology (7th ed). Boca Raton: CRC Press.

Lynch C, Sakamuru S, Ooka M, Huang R, Klumpp-Thomas C, Shinn P, Gerhold D, Rossoshek A, Michael S, Casey W, Santillo MF, Fitzpatrick S, Thomas RS, Simeonov A, Xia M. 2023. High-throughput screening to advance in vitro toxicology: accomplishments, challenges, and future directions. Ann Rev Pharmacol Toxicol 64:3.1-3.19. https://doi.org/10.1146/annurev-pharmtox-112122-104310.

Magurany KA, Chang X, Clewell R, Coecke S, Haugabrooks E, Marty S. 2023. A pragmatic framework for the application of new approach methodologies in one health toxicological risk assessment. Toxicol Sci. 192(2):155–77. https://doi.org/10.1093/toxsci/kfad012.

Natsch A, Kleinstreuer N, Astruriol D. 2023. Reduced specificity for the local lymph node assay for lipophilic chemicals: implications for the validation of new approach methods for skin sensitization. Reg Toxicol Pharmacol 138:10533. https://doi.org/10.1016/j.yrtph.2023.105333.

Petersen EJ, Elliott JT, Gordon J, Kleinstreuer NC, Reinke E, Rosslein M, Toman B. 2023. Technical framework for enabling high-quality measurements in new approach methodologies (NAMs). ALTEX 40(1):174-186. https://doi.org/10.14573/altex.2205081.

Reardon AJF, Farmahin R, Williams A, Meier MJ, Addicks GC, Yauk CL, Matteo G, Atlas E, Harrill J, Everett LJ, Shah I, Judson R, Ramaiahgari S, Ferguson SS, Barton-Maclaren TS. 2023. From vision toward best practices: Evaluating in vitro transcriptomic points of departure for application in risk assessment using a uniform workflow. Front Toxicol. https://doi.org/10.3389/ftox.2023.1194895.

Sanvido O, Basketter DA, Berthet A, Bloch D, Ezendam J, Hopf NB, Kleinstreuer N, Merolla LL, Uter W, Wiemann C, Wilks MF. 2023. Quantitative risk assessment of skin sensitising pesticides: Clinical and toxicological considerations. Reg Toxicol Pharmacol 144:105493. https://doi.org/10.1016/j.yrtph.2023.105493.

Sharma M, Stucki AO, Verstraelen S, Stedeford TJ, Jacobs A, Maes F, Poelmans D, Van Laer J, Remy S, Frijns E, Allen DG, Clippinger AJ. 2023. Human cell-based in vitro systems to assess respiratory toxicity: A case study using silanes. Toxicol Sci 195(2):213-230. https://doi.org/10.1093/toxsci/kfad074.

Smith-Roe SL, Swartz CD, Rashid A, Christy NC, Sly JE, Chang X, Sipes NS, Shockley KR,
Harris SF, McBride SJ, Larson GJ, Collins BJ, Mutlu E, Witt KL. 2023. Evaluation of the herbicide glyphosate, (aminomethyl)phosphonic acid, and glyphosate-based formulations for genotoxic activity using in vitro assays. Environ Mol Mutagen 64(4):202-233. https://doi.org/10.1002/em.22534.
Noted as an Intramural paper of the Month in the NIEHS Environmental Factor, April 2023.

Sakolish C, Moyer HL, Tsai HD, Ford LC, Dickey AN, Wright FA, Han G, Bajaj P, Baltazar MT, Carmichael PL, Stanko JP, Ferguson SS, Rusyn I. 2023. Analysis of reproducibility and robustness of a renal proximal tubule microphysiological system OrganoPlate® 3-lane 40 for in vitro studies of drug transport and toxicity. Toxicol Sci 196(1):52-70. https://doi.org/10.1093/toxsci/kfad080.

Salminen AT, Davis KJ, Felton RP, Nischal N, VonTungeln LS, Beland FA, Derr K, Brown PC, Ferrer M, Katz LM, Kleinstreuer NC, Leshin J, Manga P, Sadrieh N, Xia M, Fitzpatrick SC, Camacho L. 2023. Parallel evaluation of alternative skin barrier models and excised human skin for dermal absorption studies in vitro. Toxicol In Vitro 64(4):202-233. https://doi.org/10.1016/j.tiv.2023.105630.

Schmeisser S, Miccoli A, von Bergen M, Berggen E, Braeuning A, Busch W, Desaintes C, Gourmelon A, Grafstrom R, Harrill J, Hartung T, Herzler M, Kass G, Kleinstreuer N, Leist M, Luijten M, Marx-Stoelting P, Poetz O, van Ravenzwaay B, Roggeband R, Rogiers V, Roth A, Sanders P, Thomas RS, Marie Vinggaard A, Vinken M, van de Water B, Luch A, Tralau T. 2023. New approach methodologies in human regulatory toxicology - Not if, but how and when! Environ Intl 178:108082. https://doi.org/10.1016/j.envint.2023.108082.

Strickland J, Abedini J, Allen DG, Gordon J, Hull V, Kleinstreuer NC, Ko HS, Matheson J, Thierse HJ, Truax J, Vanselow J, Herzler M. 2023. A database of human predictive patch test data for skin sensitization. Arch Toxicol 97:2825-2837. https://doi.org/10.1007/s00204-023-03530-3.

Strickland J, Haugabrooks E, Allen DG, Balottin LB, Hirabayashi Y, Kleinstreuer NC, Kojima H, Nishizawa C, Prieto P, Ratzlaff DE, Jeong J, Lee J, Yang Y, Lin P, Sullivan K, Casey W. 2023. International regulatory uses of acute systemic toxicity data and integration of new approach methodologies. Crit Rev Toxicol 53(7);385-411. https://doi.org/10.1080/10408444.2023.2240852.

To KT, Kleinstreuer N, Vasiliou V, Hogberg HT. 2023. New approach methodologies to address population variability and susceptibility. Human Genomics 17:56. https://doi.org/10.1186/s40246-023-00502-7.

van der Zalm AJ, Daniel AB, Raabe HA, Choksi N, Flint Silva T, Breeden-Alemi J, O'Dell L, Kleinstreuer NC, Lowit AM, Allen DG, Clippinger AJ. 2023. Defined approaches to classify agrochemical formulations into EPA hazard categories developed using EpiOcular^TM reconstructed human corneal epithelium and bovine corneal opacity and permeability assays. Cut Ocular Toxicol. https://doi.org/10.1080/15569527.2023.2275029.

Vliet SMF, Markey KJ, Lynn SG, Adetona A, Fallacara D, Ceger P, Choksi N, Karmaus AL, Watson A, Ewans A, Daniel AB, Hamm J, Vitense K, Wolf KA, Thomas A, LaLone CA. 2023. Weight of evidence for cross-species conservation of androgen receptor-based biological activity. Toxicol Sci 193(2):131-145. https://doi.org/10.1093/toxsci/kfad038.

Baran SW, Brown PC, Baudy AR, Fitzpatrick SC, Frantz C, Fullerton A, Gan J, Hardwick RN, Hillgren KM, Kopec AK, Liras JL, Mendrick DL, Nagao R, Proctor WR, Ramsden D, Ribeiro AJS, Stresser D, Sung KE, Sura R, Tetsuka K, Tomlinson L, Van Vleet T, Wagoner MP, Wang Q, Arslan SY, Yoder G, Ekert JE. 2022. Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate). ALTEX 39(2):297-314. https://doi.org/10.14573/altex.2112203.

Borba JVB, Alves VM, Braga RC, Korn DR, Overdahl K, Silva AC, Hall SUS, Overdahl E, Kleinstreuer N, Strickland J, Allen D, Andrada CH, Muratov EN, Tropsha A. 2022. STopTox: An in silico alternative to animal testing for acute systemic and topical toxicity. Environ Health Perspect 130(2):027012. https://doi.org/10.1289/EHP9341.

Carlson JM, Janulewicz PA, Kleinstreuer NC, Heiger-Bernays W. 2022. Impact of high-throughput model parameterization and data uncertainty on thyroid-based toxicological estimates for pesticide chemicals. Environ Sci Technol 56(9):5620-5631. https://doi.org/10.1021/acs.est.1c07143.

Ceger P, Garcia-Reyero Vinas N, Allen D, Arnold E, Bloom R, Brennan JC, Clarke C, Eisenreich K, Fay K, Hamm J, Henry PFP, Horak K, Hunter W, Judkins D, Klein P, Kleinstreuer N, Koehrn K, LaLone CA, Laurenson JP, Leet JK, Lowit A, Lynn SG, Norberg-King T, Perkins EJ, Petersen EJ, Rattner BA, Sprankle CS, Steeger T, Warren JE, Winfield S, Odenkirchen E. 2022. Current ecotoxicity testing needs among selected U.S. federal agencies. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2022.105195.

Chang X, Palmer J, Lumen A, Lee UJ, Ceger P, Mansouri K, Sprankle C, Donley E, Bell S, Knudsen TB, Wambaugh J, Cook B, Allen D, Kleinstreuer N. 2022. Quantitative in vitro to in vivo extrapolation for developmental toxicity potency of valproic acid analogues. Birth Defects Res 114:1037-1055. https://doi.org/10.1002/bdr2.2019.
Winner, 2023 James G. Wilson Publication Award for the best paper published in Birth Defects Research in 2022.

Chang X, Tan YM, Allen DG, Bell S, Brown PC, Browning L, Ceger P, Gearhart J, Hakkinen PJ, Kabadi SV, Kleinstreuer NC, Lumen A, Matheson J, Paini A, Pangburn HA, Petersen EJ, Reinke EN, Ribeiro AJS, Sipes N, Sweeney LM, Wambaugh JF, Wange R, Wetmore BA, Mumtaz M. 2022. IVIVE: facilitating the use of in vitro toxicity data in risk assessment and decision making. Toxics 10(5):232. https://doi.org/10.3390/toxics10050232.
Recognized by Toxics as an "Annual Recommended Review for 2022"

Corton JC, Liu J, Kleinstreuer N, Gwinn MR, Ryan N. 2022. Towards replacement of animal tests with in vitro assays: a gene expression biomarker predicts in vitro and in vivo estrogen receptor activity. Chem Biol Interact. https://doi.org/10.1016/j.cbi.2022.109995.

Daniel AB, Choksi N, Abedini J, Bell S, Ceger P, Cook B, Karmaus AL, Rooney J, To KT, Allen D, Kleinstreuer. Data curation to support toxicity assessments using the Integrated Chemical Environment. Front Toxicol. https://doi.org/10.3389/ftox.2022.987848.

Eccles KM, Karmaus AL, Kleinstreuer NC, Parham F, Rider CV, Wambaugh JF, Messier KP. 2022. A geospatial modeling approach to quantifying the risk of exposure to environmental chemical mixtures via a common molecular target. Sci Total Environ. https://doi.org/10.1016/j.scitotenv.2022.158905.

Felter SP, Bhat VS, Botham PA, Bussard DA, Casey W, Hayes AW, Hilton GM, Magurany KA, Sauer UG, Ohanian EV. 2022. Assessing chemical carcinogenicity: hazard identification, classification, and risk assessment. Insight from a Toxicology Forum state-of-the-science workshop. Crit Rev Toxicol 51(8):653-694. https://doi.org/10.1080/10408444.2021.2003295.

Hamm J, Mahapatra D, Knuth MM, Abedini J, Lingerfelt M, Ekins S, Kullman SW. 2022. Confirmation of high-throughput screening data and novel mechanistic insights into FXR-xenobiotic interactions by orthogonal assays. Curr Res Toxicol 3:100092. https://doi.org/10.1016/j.crtox.2022.100092.

Hilton GM, Adcock C, Akerman G, Baldassari J, Battalora M, Casey W, Clippinger AJ, Cope R, Goetz A, Hayes AW, Papineni S, Peffer RC, Ramsingh D, Riffle BW, Sanches da Rocha M, Ryan N, Scollon E, Visconti N, Wolf DC, Yan Z, Lowit A. 2022. Rethinking chronic toxicity and carcinogenicity assessment for agrochemicals project (ReCAAP): A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays. Regul Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2022.105160.

Hines DE, Bell S, Chang X, Mansouri K, Allen D, Kleinstreuer N. 2022. Application of an accessible interface for pharmacokinetic modeling and in vitro to in vivo extrapolation. Front Pharmacol. https://doi.org/10.3389/fphar.2022.864742.

Hogberg HT, Lam A, Ohayon E, Shahbaz MA, Clerbaux LA, Bal-Price A, Coecke S, Concha R, De Bernardi F, Edrosa E, Hargreaves AJ, Kanninen KM, Munoz A, Pistollato F, Saravanan S, Garcia-Reyero N, Wittwehr C, Sachana M. 2022. The adverse outcome pathway framework applied to neurological symptoms of COVID-19. Cells. https://www.mdpi.com/2073-4409/11/21/3411.

Karmaus AL, Mansouri K, To KT, Blake B, Fitzpatrick J, Strickland J, Patlewicz G, Allen D, Casey W, Kleinstreuer N. 2022. Evaluation of variability across rat acute oral systemic toxicity studies. Toxicol Sci 188(1):34-47. https://doi.org/10.1093/toxsci/kfac042.

Krishna S, Borrel A, Huang R, Zhao J, Xia M, Kleinstreuer N. 2022. High-throughput chemical screening and structure-based models to predict hERG inhibition. Biology 11(2):209. https://doi.org/10.3390/biology11020209.

Lee KM, Corley R, Jarabek AM, Kleinstreuer N, Paini A, Stucki AO, Bell S. 2022. Advancing new approach methodologies (NAMs) for tobacco harm reduction: synopsis from the 2021 COREST SSPT–NAMs symposium. Toxics 10(12): 760. https://doi.org/10.3390/toxics10120760.

Petersen EJ, Ceger P, Allen DG, Coyle J, Derk R, Garcia-Reyero N, Gordon J, Kleinstreuer N, Matheson J, McShan D, Nelson BC, Patri AK, Rice P, Rojanasakul L, Sasidharan A, Scarano L, Chang X. 2022. U.S. federal agency interests and key considerations for new approach methodologies for nanomaterials. ALTEX 39(2):183-206. https://doi.org/10.14573/altex.2105041.

Petersen EJ, Uhl R, Toman B, Elliott JT, Strickland J, Truax J, Gordon J. 2022. Development of a 96-well electrophilic allergen screening assay for skin sensitization using a measurement science approach. Toxics 10(5):257. https://doi.org/10.3390/toxics10050257.

Rogers B, Brown J, Allen DG, Casey W, Clippinger AJ. 2022. Replacement of in vivo leptospirosis vaccine potency testing in the United States. Biologicals 78:36-44. https://doi.org/10.1016/j.biologicals.2022.05.001.

Sedykh A, Choksi NY, Allen DG, Casey WM, Shah R, Kleinstreuer NC. 2022. Mixtures-inclusive in silico models of ocular toxicity based on United States and international hazard categories. Chem Res Toxicol 35(6):992-1000. https://doi.org/10.1021/acs.chemrestox.1c00443.

Strickland J, Allen DG, Germolec D, Kleinstreuer N, Johnson VJ, Gulledge T, Truax J, Lowit A, Dole T, McMahon T, Panger M, Facey J, Savage S. 2022. Application of defined approaches to assess skin sensitization potency of isothiazolinone compounds. Appl In Vitro Toxicol 8(2)117-128. https://doi.org/10.1089/aivt.2022.0014.
Rosalind Franklin Society Award in Science awarded to Judy Strickland as first author of this paper.

Strickland J, Truax J, Corvaro M, Settivari R, Henriquez J, McFadden J, Gulledge T, Johnson V, Gehen S, Germolec DG, Allen D, Kleinstreuer N. 2022. Application of defined approaches for skin sensitization to agrochemical products. Front Toxicol. https://doi.org/10.3389/ftox.2022.852856.

Thessen AE, Marvel S, Achenbach JC, Fischer S, Haendel MA, Hayward K, Klüver N, Könemann S, Legradi J, Lein PJ, Leong C, Muriana A, Mylroie JE, Padilla S, Perone D, Planchart A, Prieto RM, Quevedo C, Reif DM, Ryan K, Stinckens E, Truong L, Vergauwen L, Vom Berg C, Wilbanks M, Yaghoobi B, Hamm J. Implementation of zebrafish ontologies for toxicology screening. Front Toxicol. https://doi.org/10.3389/ftox.2022.817999.

van der Zalm AJ, Barroso J, Browne P, Casey W, Gordon J, Henry TR, Kleinstreuer NC, Lowit AB, Perron M, Clippinger AJ. 2022. A framework for establishing scientific confidence in new approach methodologies. Arch Toxicol 96(11):2865-2879. https://doi.org/10.1007/s00204-022-03365-4.

Abedini JA, Cook B, Bell S, Chang X, Choksi N, Daniel AB, Hines D, Karmaus AL, Mansouri K, McAfee E, Phillips J, Rooney J, Sprankle CS, Allen D, Casey W, Kleinstreuer N. 2021. Application of new approach methodologies: ICE tools to support chemical evaluations. Comput Toxicol. https://doi.org/10.1016/j.comtox.2021.100184.

Allen D, Rooney J, Kleinstreuer N, Lowit A, Perron M. 2021. Retrospective analysis of dermal absorption triple pack data. ALTEX 38(3):463-476. PMID 33712859.

Alves VM, Auerbach SS, Kleinstreuer NC, Rooney JP, Muratov EN, Rusyn I, Tropsha A, Schmitt C. 2021. Curated data in — trustworthy in silico models out: the impact of data quality on the reliability of artificial intelligence models as alternatives to animal testing. ATLA 49(3):73-82. PMID 34233495.

Bassan A, Alves V, Amberg A, Anger LT, Auerbach S, Beilke L, Bender A, Cronin MTD, Cross KP, Hsieh JH, Greene N, Kemper R, Kim MT, Mumtaz M, Noeske T, Pavan M, Pletz J, Russo DP, Sabnis Y, Schaefer M, Szabo DT, Valentin JP, Wichard J, Williams D, Wooley D, Zwickl C, Myatt GJ. 2021. In silico approaches in organ toxicity hazard assessment: Current status and future needs in predicting liver toxicity. Comput Toxicol. https://doi.org/10.1016/j.comtox.2021.100187.

Bassan A, Alves V, Amberg A, Anger LT, Beilke L, Bender A, Bernal A, Cronin MTD, Hsieh JH, Johnson C, Kemper R, Mumtaz M, Nielson L, Pavan M, Pointon A, Pletz J, Ruiz P, Russo DP, Sabnis Y, Sandhu R, Schaefer M, Stavitskaya L, Szabo DT, Valentin JP, Wooley D, Zwickl C, Myatt GJ. 2021. In silico approaches in organ toxicity hazard assessment: Current status and future needs for predicting heart, kidney and lung toxicities. Comput Toxicol. https://doi.org/10.1016/j.comtox.2021.100188.

Borba J, Braga RC, Alves VM, Muratov EN, Kleinstreuer NC, Tropsha A, Andrade CH. 2021. Pred-Skin: A web portal for accurate prediction of human skin sensitizers. Chem Res Toxicol 34(2):258-267. PMID 32673477.

Brown J, Clippinger AJ, Briglia CF, Casey W, Coleman K, Fritsch A, Hartung T, Maouyo D, Muller T, Reich J, Robert L, Roeder R, Sanchez G, Sawyer AY, Solati S, Tirumalai R, Zwisler W, Allen D. 2021. Using the monocyte activation test as a stand-alone release test for medical devices. ALTEX 38(1):151-156. PMID 33452530.

Clippinger AJ, Raabe HA, Allen DG, Choksi N, van der Zalm A, Kleinstreuer N, Barroso J, Lowit AB. 2021. Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Cutan Ocul Toxicol 40(2):145-167. PMID 33830843.

Eskes C, Casati S, Kleinstreuer N, Ezendam J. 2021. Usefulness and applicability of integrated strategy approaches in toxicology. Appl In Vitro Toxicol 7(3):89-90.

Hagstrom A, Anastas P, Boissevain A, Borrel A, Deziel N, Fenton S, Fields C, Fortner J, Franceschi-Hofmann N, Frigon R, Jin L, Kim JH, Kleinstreuer N, Koelmel J, Lei Y, Liew Z, Ma X, Mathieu L, Nason S, Organtini K, Oulhote Y, Pociu S, Godri Pollitt K, Saiers J, Thompson D, Toal B, Weiner E, Whirledge S, Zhang Y, Vasiliou V. 2021. Yale School of Public Health Symposium: An overview of the challenges and opportunities associated with per- and polyfluoroalkyl substances (PFAS). Sci Total Environ 778:146192. PMID 33714836.

Hamm J, Allen D, Ceger P, Flint T, Lowit A, O'Dell L, Tao J, Kleinstreuer N. 2021. Performance of the GHS Mixtures Equation for predicting acute oral toxicity. Reg Toxicol Pharmacol. PMID 34298086. https://doi.org/10.1016/j.yrtph.2021.105007.

Jain S, Siramshetty VB, Alves VN, Muratov EN, Kleinstreuer NC, Tropsha A, Nicklaus MC, Simeonov N, Zakharov AV. 2021. Large-scale modeling of multispecies acute toxicity end points using consensus of multitask deep learning methods. J Chem Inf Modeling 61(2):653-663. PMID 33533614.

Kleinstreuer N, Holmes A. 2021. Harnessing the power of microphysiological systems for COVID-19 research. Drug Discov Today 26(11):2496-2501. PMID 34332095.

Knudsen TB, Fitzpatrick SC, De Abrew KN, Birnbaum LS, Chappelle A, Daston GP, Dolinoy DC, Elder A, Euling S, Faustman EM, Fedinick KP, Fransoza JA, Haggard DE, Haws L, Kleinstreuer N, Louis GMB, Mendrick DL, Rudel R, Saili KS, Schug TT, Tanguay RL, Turley AE, Wetmore BA, White KW, Zurlinden TJ. 2021. FutureTox IV workshop summary: Predictive Toxicology for Healthy Children. Toxicol Sci 180(2):198-211. PMID 33555348.

Krishna S, Berridge B, Kleinstreuer NC. 2021. High-throughput screening to identify chemical cardiotoxic potential. Chem Res Toxicol 34(2):566-583. PMID 33346635.

Mansouri K, Karmaus AL, Fitzpatrick J, Patlewicz G, Pradeep P, Alberga D, Alepee N, Allen THE, Allen DG, Alves VM, Andrade CH, Auernhammer TR, Ballabio D, Bell S, Benfenati E, Bhattacharya S, Bastos JV, Boyd S, Brown JB, Capuzzi SJ, Chushak Y, Ciallella H, Clark AM, Consonni V, Daga PR, Ekins S, Farag S, Fedorov M, Fourches D, Gadaleta D, Gao F, Gearhart JM, Goh G, Goodman JM, Grisoni F, Grulke CM, Hartung T, Hirn M, Karpov P, Korotcov A, Lavado GJ, Lawless M, Li X, Luechtefeld T, Lunghini F, Mangiatordi GF, Marcou G, Marsh D, Martin T, Mauri A, Muratov EN, Myatt GJ, Nguyen DT, Nicolotti O, Note R, Pande P, Parks AK, Peryea T, Polash AH, Rallo R, Roncaglioni A, Rowlands C, Ruiz P, Russo DP, Sayed A, Sayre R, Sheils T, Siegel C, Silva AC, Simeonov A, Sosnin S, Southall N, Strickland J, Tang Y, Teppen B, Tetko IV, Thomas D, Tkachenko V, Todeschini R, Toma C, Tripodi I, Trisciuzzi D, Tropsha A, Varnek A, Vukovic K, Wang Z, Wang L, Waters KM, Wedlake AJ, Wijeyesakere SJ, Wilson D, Xiao Z, Yang H, Zahoranszky-Kohalmi G, Zakharov AV, Zhang FF, Zhang Z, Zhao T, Zhu H, Zorn KM, Casey W, Kleinstreuer NC. 2021. CATMoS: Collaborative Acute Toxicity Modeling Suite. Environ Health Perspect 129:47013. PMID 33929906.

Moreira-Filho JT, Braga RC, Lemos JM, Alves VM, Borba JVVB, Costa WS, Kleinstreuer N, Muratov EN, Andrade CH, Neves BJ. 2021. BeeToxAI: An artificial intelligence-based web app to assess acute toxicity of chemicals to honey bees. Artif Intell Life Sciences 1:100013. https://doi.org/10.1016/j.ailsci.2021.100013.

Pamies D, Leist M, Coecke S, Bowe G, Allen DG, Gstraunthaler G, Bal-Price A, Pistollato F, de Vries RBM, Hogberg HT, Hartung T, Stacey G. 2021. Guidance document on good cell and tissue culture practice 2.0. ALTEX 39(1):30-70. PMID 34882777. https://doi.org/10.14573/altex.2111011.

Patel V, Amin K, Allen D, Ukishima L, Wahab A, Grodi C, Behrsing H. 2021. Comparison of long-term human precision-cut lung slice culture methodology and response to challenge: an argument for standardization. Altern Lab Anim 49(5):209-222. PMID 34836458.

Petersen E, Nguyen A, Brown J, Elliot J, Clippinger A, Gordon J, Kleinstreuer N, Roesslein M. 2021. Characteristics to consider when selecting a positive control material for an in vitro assay. ALTEX 38(2):365-376. PMID 33637998.

Petersen E, Sharma M, Clippinger A, Gordon J, Katz A, Laux P, Leibrock LB, Luch A, Matheson J, Stucki AO, Tentschert J, Bierkandt FS. 2021. Use of cause-and-effect analysis to optimize the reliability of in vitro inhalation toxicity measurements using an air-liquid interface. Chem Res Toxicol 34(6):1370-1385. PMID 34097823.

Richard AM, Huang R, Waidyanatha S, Shinn P, Collins BJ, Thillaindarajah I, Grulke CM, Williams AJ, Lougee RR, Judson RS, Houck KE, Shobair M, Yang C, Rathman JF, Yasgar A, Fitzpatrick SC, Simeonov A, Thomas RS, Crofton KM, Paules RS, Bucher JR, Austin CP, Kavlock RJ, Tice RR. 2021. The Tox21 compound library: collaborative chemistry advancing toxicology. Chem Res Toxicol 34(2):189-216. PMID 33140634.

Rooney JP, Choksi NY, Ceger P, Daniel AB, Truax J, Allen DG, Kleinstreuer NC. 2021. Analysis of variability in the rabbit skin irritation assay. Regul Toxicol Pharmacol 122:104920. PMID 33757807.

Sedykh AY, Shah RR, Kleinstreuer NC, Auerbach SS, Gombar VK. 2021. Saagar - a new, extensible set of molecular substructures for QSAR/QSPR and read-across predictions. Chem Res Toxicol 34(2):634-640. PMID 33356152.

Silva AC, Borba JVVB, Alves VM, Hall SUS, Furnham N, Kleinstreuer N, Muratov E, Tropsha A, Andrade CA. 2021.Novel computational models offer alternatives to animal testing for assessing eye irritation and corrosion potential of chemicals. Artif Intell Life Sciences 1:10028. https://doi.org/10.1016/j.ailsci.2021.100028.

Sullivan K, Allen DG, Clippinger AJ, Wilson DM, Edwards SW, Glover K, Mansouri K, Settivari R, Wijeyesakere S, Casey W. 2021. Mind the gaps: prioritizing activities to meet regulatory needs for acute systemic lethality. ALTEX 38(2):327-335.

Tan YM, Barton HA, Boobis A, Brunner R, Clewell H, Cope R, Dawson J, Domoradzki J, Egeghy P, Gulati P, Ingle B, Kleinstreuer N, Lowe K, Lowit A, Mendez E, Miller D, Minucci J, Nguyen J, Paini A, Perron M, Phillips K, Qian H, Ramanarayanan T, Sewell F, Villanueva P, Wambaugh J, Embry M. 2021. Opportunities and challenges related to saturation of toxicokinetic processes: implications for risk assessment. Reg Toxicol Pharmacol. PMID 34718074. https://doi.org/10.1016/j.yrtph.2021.105070.

Tandon A, Howard B, Ramaiahgari S, Maharana A, Ferguson S, Shah R, Merrick BA. 2021. Deep learning image analysis of high-throughput toxicology assay images. SLAS Discov 27(1):29-38. PMID 35058173.

Bell S, Abedini J, Ceger P, Chang X, Cook B, Karmaus AL, Lea I, Mansouri K, Phillips J, McAfee E, Rai R, Rooney J, Sprankle C, Tandon A, Allen D, Casey W, Kleinstreuer N. 2020. An integrated chemical environment with tools for chemical safety testing. Toxicol In Vitro 67:104916. PMID 32553663.

Borrel A, Auerbach S, Houck KA, Kleinstreuer NC. 2020. Tox21BodyMap: a webtool to map chemical effects on the human body. Nucleic Acids Res 48(W1):W472-W476. PMID 32491175. Intramural paper of the month, NIEHS Environmental Factor August 2020.

Borrel A, Huang R, Sakamuru S, Xia M, Simeonov A, Mansouri K, Houck KA, Judson RS, Kleinstreuer NC. 2020. High-throughput screening to predict chemical-assay interference. Sci Rep 10:3986. PMID 32132587.

Borrel A, Mansouri K, Nolte S, Saddler T, Conway M, Schmitt C, Kleinstreuer NC. 2020. InterPred: a webtool to predict chemical autofluorescence and luminescence interference. Nucleic Acids Res 48(W1):W586–W590. PMID 32421835.

Choksi N, Lebrun S, Nguyen M, Daniel A, DeGeorge G, Willoughby J, Layton A, Lowther D, Merrill J, Matheson J, Barroso J, Yozzo K, Casey W, Allen D. 2020. Validation of the OptiSafe™ eye irritation test . Cutan Ocul Toxicol 39(3):180-192. PMID 32586141.
Winner, Paper of the Year (2020), Society of Toxicology Ocular Toxicity Specialty Section

Comess S, Akbay A, Vasiliou M, Hines RN, Joppa L, Vasiliou V, Kleinstreuer N. 2020. Bringing big data to bear in environmental health: challenges and recommendations. Front Artif Intell 3:31. PMID 33184612.

Groff K, Allen D, Casey W, Clippinger A. 2020. Increasing the use of animal-free recombinant antibodies. ALTEX 37(2):309-311. PMID 31923318.

Judson R, Houck K, Paul Friedman K, Brown J, Browne P, Johnston PA, Close DA, Mansouri K, Kleinstreuer N. 2020. Selecting a minimal set of androgen receptor assays for screening chemicals. Reg Toxicol Pharmacol 117:104764. PMID 32798611.

Kleinstreuer NC, Tong W, Tetko IV. 2020. Computational toxicology [Editorial]. Chem Res Toxicol 33(3):687-688. PMID 32172570.

Li X, Kleinstreuer NC, Fourches D. 2020. Hierarchical quantitative and structure-activity relationship modeling approach for integrating binary, multiclass, and regression models of acute oral systemic toxicity. Chem Res Toxicol 33(2):353-366. PMID 31975586.

Mansouri K, Kleinstreuer N, Abdelaziz AM, Alberga D, Alves VM, Andersson PL, Andrade CH, Bai F, Balabin I, Ballabio D, Benfenati E, Bhhatari B, Boyer S, Chen J, Consonni V, Farag S, Fourches D, Garcia-Sosa AT, Gramatica P, Grisoni F, Grulke CM, Hong H, Horvath D, Hu X, Huang R, Jeliazkova N, Li J, Li X, Liu H, Manganelli S, Mangiatordi GF, Maran U, Marcou G, Martin T, Muratov E, Nguyen DT, Nicolotti O, Nikolov NG, Norinder U, Papa E, Petitjean M, Piir G, Pogodin P, Poroikov V, Qiao X, Richard AR, Roncaglioni A, Ruiz P, Rupakheti C, Sakkiah S, Sangion A, Schramm KW, Selvaraj C, Shah I, Sild S, Sun L, Taboureau O, Tang Y, Tetko IV, Todeschini R, Tong W, Trisciuzzi D, Tropsha A, Ven Den Driessche G, Varnek A, Wang Z, Wedebye EB, Williams A, Xie H, Zakharov AV, Zheng Z, Judson RS. 2020. CoMPARA: Collaborative Modeling Project for Androgen Receptor Activity. Environ Health Perspect 128(2):027002.

Nelms MD, Karmaus AL, Patlewicz G. 2020. An evaluation of the performance of selected (Q)SARs/expert systems for predicting acute oral toxicity. Comput Toxicol 16:100135. PMID 33163737.

Parish ST, Aschner M, Casey W, Corvaro M, Embry MR, Fitzpatrick S, Kidd D, Kleinstreuer NC, Lima BS, Settivari RS, Wolf DC, Yamazaki D, Boobis A. 2020. An evaluation framework for new approach methodologies (NAMs) for human health safety assessment. Reg Toxicol Pharmacol 112:104592. PMID 32017962.

Prior H, Baldrick P, Beken S, Booler S, Bower N, Brooker P, Brown P, Burlinson B, Burns-Naas LA, Casey W, Chapman M, Clarke D, de Haan L, Doehr O, Downes N, Flaherty M, Gellatly N, Moesgaard SG, Harris J, Holbrook M, Hui J, Jones D, Jones K, Kedar H, Mahl A, Manninen A, McGuire A, Mortimer-Cassen E, Peraza M, Pugsley MK, Richard J, Roberts R, Roosen W, Rothfuss A, Schoenmakers A, Sewell F, Weaver R, Weir L, Wolfreys A, Kimber I. 2020. Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation. Reg Toxicol Pharmacol 113:104624. PMID 32126256.

Rovida C, Barton-Maclaren T, Benfenati E, Caloni F, Chandrasekera C, Chesne C, Cronin MTD, De Knecht J, Dietrich DR, Escher SE, Fitzpatrick S, Flannery B, Herzler M, Hougaard Bennekou S, Hubesch B, Kamp H, Kisitu J, Kleinstreuer N, Kovarich S, Leist M, Maertens A, Nugent K, Pallocca G, Pastor M, Patlewicz G, Pavan M, Presgrave O, Smirnova L, Schwarz M, Yamada T, Hartung T. 2020. Internationalization of read-across as a validation new approach method (NAM) for regulatory toxicology. ALTEX 37(4):579-606. PMID 32369604.

Smith MT, Guyton KZ, Kleinstreuer N, Borrel A, Cardenas A, Chiu WA, Felsher DW, Gibbons CF, Goodson WH, Houck KA, Kane AB, La Merrill MA, Lebrec H, Lowe L, McHale CM, Minocherhomji S, Rieswijk L, Sandy MS, Sone H, Wang A, Zhang L, Zeise L, Fielden M. 2020. The key characteristics of carcinogens: relationship to the hallmarks of cancer, relevant biomarkers, and assays to measure them. Cancer Epidemiol Biomarkers Prev 29:1887-1903. PMID 32152214.

Wei Z, Liu X, Ooka M, Zhang L, Song MJ, Huang R, Kleinstreuer NC, Simeonov A, Xia M, Ferrer M. 2020. Two-dimensional cellular and three-dimensional bio-printed skin models to screen topical-use compounds for irritation potential. Front Bioeng Biotechnol 8:109.

Alberga D, Trisciuzzi D, Mansouri K, Mangiatordi GF, Nicolotti O. 2019. Prediction of acute oral systemic toxicity using a multifingerprint similarity approach. Toxicol Sci 167(2):484-495. PMID 30371864.

Bernasconi C, Pelkonen O, Andersson TB, Strickland J, Wilk-Zasadna I, Asturiol D, Cole T, Liska R, Worth A, Müller-Vieira U, Richert L, Chesne C, Coecke S. 2019. Validation of in vitro methods for human cytochrome P450 enzyme induction: Outcome of a multi-laboratory study. Toxicol In Vitro 60:212-228. PMID 31158489.

Burgdorf T, Peirsma AH, Landsiedel R, Clewell R, Kleinstreuer N, Oelgeschlager M, Desprez B, Kienhuis A, Bos P, de Vries R, de Wit L, Seidle T, Scheel J, Schonfelder G, van Benthem J, Vinggard AM, Eskes C, Ezendam J. 2019. Workshop on the validation and regulatory acceptance of innovative 3R approaches in regulatory toxicology - evolution versus revolution. Toxicol In Vitro 59:1-11. PMID 30946968.

Casey W, Lowit A. 2019. USA: ICCVAM and NICEATM. In: Balls M, Combes R, Worth A. 2019. The History of Alternative Test Methods in Toxicology. London: Academic Press. https://doi.org/10.1016/B978-0-12-813697-3.00015-9

Choksi NY, Truax J, Layton A, Matheson J, Mattie D, Varney T, Tao J, Yozzo K, McDougal AJ, Merrill J, Lowther D, Barroso J, Linke B, Casey W, Allen D. 2019. United States regulatory requirements for skin and eye irritation testing. Cutan Ocular Toxicol 38(2):141-155. PMID 30418044.

Corton JC, Kleinstreuer NC, Judson RS. 2019. Identification of potential endocrine disrupting chemicals using gene expression biomarkers. Toxicol Appl Pharmacol 380:114683. PMID 31325560.

Fujita M, Yamamoto Y, Watanabe S, Sugawara T, Wakabayashi K, Tahara Y, Horie N, Fujimoto K, Kusakari K, Kurokawa Y, Kawakami T, Kojima K, Sozu T, Nakayama T, Kusao T, Richmond J, Kleinstreuer N, Kim B-H, Kojima H, Kasahara T, Ono T. 2019. The within- and between-laboratory reproducibility and predictive capacity of the in chemico amino acid derivative reactivity assay: Results of validation study implemented in four participating laboratories. J Appl Toxicol 39(11)1492-1505. PMID 31313332.

Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. 2019. Chronic inflammation in the etiology of disease across the life span. Nat Med 25(12):1822-1832. PMID 31806905.

Gadaleta D, Vukovic K, Toma C, Lavado GJ, Karmaus AL, Mansouri K, Kleinstreuer NC, Benfenati E, Roncaglioni A. 2019. SAR and QSAR modeling of a large collection of LD50 rat acute oral toxicity data. J Cheminfor 11, 58.

Hamm JT, Ceger P, Allen D, Stout M, Maull EA, Baker G, Zmaroski A, Padilla S, Perkins E, Planchart A, Stedman D, Tal T, Tanguay RL, Volz DC, Wilbanks MS, Walker NJ. 2019. Characterizing sources of variability in zebrafish embryo screening protocols. ALTEX 36(1):103-120. PMID 30415271.

Kojima H, Yamaguchi H, Sozu T, Kleinstreuer N, Chae-Hyung L, Chen W, Watanabe M, Fukuda T, Yamashita K, Takezawa K. 2019. Multi-laboratory validation study of the Vitrigel-Eye Irritancy Test Method as an alternative to in vivo eye irritation testing. Altern Lab Anim 47(3-4):140-157. PMID: 31838865.

Kolanjiyil AV, Kleinstreuer C, Kleinstreuer NC, Pham W, Sadikot RT. 2019. Mice-to-men comparison of inhaled drug-aerosol deposition and clearance. Respir Physiol and Neurobiol 260:82-94. PMID 30445230.

Manganelli S, Roncaglioni A, Mansouri K, Judson RS, Benfenati E, Manganaro A, Ruiz P. 2019. Development, validation and integration of in silico models to identify androgen active chemicals. Chemosphere 220:204-215. PMID 30584954.

Mansouri K, Cariello NF, Korotcov A, Tkachenko V, Grulke CM, Sprankle CS, Allen D, Casey WM, Kleinstreuer NC, Williams AJ. 2019. Open-source QSAR models for pKa prediction using multiple machine learning approaches. J Cheminfor 11:60.

Patlewicz G, Lizarraga L, Rua D, Allen DG, Daniel A, Fitzpatrick SC, Garcia-Reyero N, Gordon J, Hakkinen P, Howard AS, Karmaus A, Matheson J, Mumtaz M, Richarz AN, Ruiz P, Scarano L, Yamada T, Kleinstreuer N. 2019. Exploring current read-across applications and needs among selected U.S. federal agencies. Regul Toxicol Pharmacol 106:197-209. PMID 31078681

Poston R, Hill R, Allen C, Casey W, Gatewood D, Levis R, Mallet L, Smith D, Srivinas G, Stirling C, Allen D. 2019. Achieving scientific and regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing: A NICEATM and IABS workshop report. Biologicals 60:8-14. PMID 31255474.

Prior H, Casey W, Kimber I, Whelan M, Sewell F. 2019. Reflections on the progress towards non-animal methods for acute toxicity testing of chemicals. Regul Toxicol Pharmacol 102:30-33. PMID 30578838.

Russo DP, Strickland J, Karmaus AL, Wang W, Shende S, Hartung T, Aleksunes LM, Zhu H. 2019. Nonanimal models for acute toxicity evaluations: applying data-driven profiling and read-across. Environ Health Perspect 127(4):47001. PMID 30933541.

Saili KS, Franzosa JA, Baker NC, Ellis-Hutchings RG, Settivari RS, Carney EW, Spencer R, Zurlinden TJ, Kleinstreuer NC, Li S, Xia M, Knudsen TB. 2019. Systems modeling of developmental vascular toxicology. Curr Opin Toxicol 15:55-63.

Solecki R, Rauch M, Gall A, Buschmann J, Kellner R, Kucheryavenko O, Schmitt A, Delrue N, Li W, Hu J, Fujiwara M, Kuwagata M, Mantovani A, Makris SL, Paumgartten F, Schonfelder G, Schneider S, Vogl S, Kleinstreuer N, Schneider M, Schulze F, Fritsche E, Clark R, K Shiota, Chahoud. 2019. Update of the DevTox data database for harmonized risk assessment and alternative methodologies in developmental toxicology: Report of the 9th Berlin Workshop on Developmental Toxicity. Reprod Toxicol 89:124-129. PMID 31288076.

Strickland J, Daniel AB, Allen D, Aguila C, Ahir S, Bancos S, Craig E, Germolec D, Ghosh C, Hudson NL, Jacobs A, Lehmann DM, Matheson J, Reinke EN, Sadrieh N, Vukmanovic S, Kleinstreuer N. 2019. Skin sensitization testing needs and data uses by U.S. regulatory and research agencies. Arch Toxicol 92(2):273-291. PMID 30377734.

Strickland J, Paris MW, Allen D, Casey W. 2019. Approaches to reducing animal use for acute toxicity testing: retrospective analyses of pesticide data. In: Kojima H, Seidle T, Spielmann H. (eds), Alternatives to Animal Testing. Springer, Singapore.

Wei Z, Sakamuru S, Zhang L, Zhao J, Huang R, Kleinstreuer NC, Chen Y, Shu Y, Knudsen TB, Xia M. 2019. Identification and profiling of environmental chemicals that inhibit the TGFβ/SMAD signaling pathway. Chem Res Toxicol 32(12):2433-2444. PMID 31652400.

Bell SM, Chang X, Wambaugh JF, Allen DG, Bartels M, Brouwer KLR, Casey WM, Choksi N, Ferguson SS, Fraczkiewicz G, Jarabek AM, Ke A, Lumen A, Lynn SG, Paini A, Price PS, Ring C, Simon TW, Sipes N, Sprankle CS, Strickland J, Troutman J, Wetmore BA, Kleinstreuer NC. 2018. In vitro to in vivo extrapolation for high throughput prioritization and decision making. Toxicol In Vitro 47:213-227.

Borrel A, Kleinstreuer NC, Fourches D. 2018. Exploring drug space with ChemMaps.com. Bioinformatics 34(21):3773-3775.

Browne P, Kleinstreuer NC, Ceger P, Deisenroth C, Baker N, Markey K, Thomas RS, Judson RJ, Casey W. 2018. Development of a curated Hershberger database. Reprod Toxicol 81:259-271.

Casati S, Aschberger K, Barroso J, Casey W, Delgado I, Kim TS, Kleinstreuer N, Kojima H, Lee JK, Lowit A, Park HK, Regimbald-Krnel MJ, Strickland J, Whelan M, Yang Y, Zuang V. 2018. Standardisation of defined approaches for skin sensitisation testing to support regulatory use and international adoption: position of the International Cooperation on Alternative Test Methods. Arch Toxicol 92:611-617.

Casey WM, Chang X, Allen DG, Ceger P, Choksi NY, Hsieh J-H, Wetmore BA, Ferguson SS, DeVito MJ, Sprankle CS, Kleinstreuer NC. 2018. Evaluation and optimization of pharmacokinetic models for in vitro to in vivo extrapolation of estrogenic activity for environmental chemicals. Environ Health Perspect 126(9):97001.

Chesnut M, Yamada T, Adams T, Knight D, Kleinstreuer N, Kass G, Luechtefeld T, Hartung T. 2018. Regulatory acceptance of read-across. ALTEX 35(3):413-419.

Clippinger AJ, Allen D, Behrsing H, BéruBé KA, Bolger MB, Casey W, DeLorme M, Gaça M, Gehen SC, Glover K, Hayden P, Hinderliter P, Hotchkiss JA, Iskandar A, Keyser B, Luettich K, Ma-Hock L, Maione AG, Makena P, Melbourne J, Milchak L, Ng SP, Paini A, Page K, Patlewicz G, Prieto P, Raabe H, Reinke EN, Roper C, Rose J, Sharma M, Spoo W, Thorne PS, Wilson DM, Jarabek AM. 2018. Pathway-based predictive approaches for non-animal assessment of acute inhalation toxicity. Toxicol In Vitro 52:131-145.
Honorable Mention winner, Best Paper of 2018, Society of Toxicology Biological Modeling Specialty Section

Clippinger AJ, Allen D, Jarabek AM, Corvaro M, Gaça M, Gehen S, Hotchkiss JA, Patlewicz G, Melbourne J, Hinderliter P, Yoon M, Huh D, Lowit A, Buckley B, Bartels M, BéruBé K, Wilson DM, Indans I, Vinken M. 2018. Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: An international workshop report. Toxicol In Vitro 48:53-70.

Daniel AB, Strickland J, Allen D, Casati S, Zuang V, Barroso J, Whelan M, Regimbald-Krnel MJ, Kojima H, Nishikawa A, Park HK, Lee JK, Kim TS, Delgado I, Rios L, Yang Y, Wang G, Kleinstreuer N. 2018. International regulatory requirements for skin sensitization testing. Regul Toxicol Pharmacol 95:52-65.

Haggard D, Karmaus AL, Martin MT, Judson RS, Setzer RW, Paul-Friedman K. 2018. High-throughput H295R steroidogenesis assay: utility as an alternative and a statistical approach to characterize effects on steroidogenesis. Toxicol Sci 162(2): 509-534.

Hoffman S, Kleinstreuer NC, Alepee N, Allen D, Api AM, Ashikaga T, Clouet E, Cluzel M, Desprez B, Gellatly N, Goebel C, Kern PS, Klaric M, Kuhnl J, Lalko JF, Martinozzi-Teisslier S, Mewes K, Miyazawa M, Parakhia R, van Vliet E, Zang Q, Petersohn D. 2018. Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database. Crit Rev Toxicol 48(5):344-358.

Judson RS, Paul Friedman K, Houck K, Mansouri K, Browne P, Kleinstreuer NC. 2018. New approach methods for testing chemicals for endocrine disruption potential. Curr Opin Toxicol 9:40-47. PMID 30570668.

Judson RS, Thomas RS, Baker N, Simha A, Howey XM, Marable C, Kleinstruer NC, Houck KA. 2018. Workflow for defining reference chemicals for assessing performance of in vitro assays. ALTEX 36(2):261-276.

Kleinstreuer NC, Browne P, Chang X, Judson R, Casey W, Ceger P, Deisenroth C, Baker N, Markey K, Thomas RS. 2018. Evaluation of androgen assay results using a curated Hershberger database. Reprod Toxicol 81:272-280.

Kleinstreuer NC, Hoffman S, Alepee N, Allen D, Ashikaga T, Casey W, Clouet E, Cluzel M, Desprez B, Gellatly N, Gobel C, Kern PS, Klaric M, Kuhnl J, Martinozzi-Teisslier S, Mewes K, Miyazawa M, Strickland J, van Vliet E, Zang Q, Petersohn D. 2018. Non-animal methods to predict skin sensitization (II): an assessment of defined approaches. Crit Rev Toxicol 48(5);359-374.
Winner, Best Paper of 2018, Society of Toxicology Risk Assessment Specialty Section

Kleinstreuer NC, Karmaus A, Mansouri K, Allen DG, Fitzpatrick JM, Patlewicz G. 2018. Predictive models for acute oral systemic toxicity: a workshop to bridge the gap from research to regulation. Computational Toxicol 8:21-24.

Mahony C, Currie R, Daston G, Kleinstreuer N, van de Water B. 2018. Highlight report: 'Big data in the 3Rs: outlook and recommendations', a roundtable summary. Arch Toxicol 92:1015-1020.

Mansouri K, Grulke CM, Judson RS, Williams AJ. 2018. OPERA models for predicting physicochemical properties and environmental fate endpoints. J Cheminform 10(1):10.

Marshall LJ, Austin CP, Casey W, Fitzpatrick SC, Willett C. 2018. Recommendations toward a human pathway-based approach to disease research. Drug Discov Today 23(11):1824-1832.

Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Burden N, Cammerer Z, Cronin MTD, Cross KP, Custer L, Dettwiler M, Dobo K, Ford KA, Fortin MC, Gad-McDonald SE, Gellatly N, Gervais V, Glover KP, Glowienke S, Van Gompel J, Gutsell S, Hardy B, Harvey JS, Hillegass J, Honma M, Hsieh J-H, Hsu C-W, Hughes K, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kim MT, Kruhlak NL, Kulkami SA, Kummerer K, Leavitt P, Majer B, Masten S, Miller S, Moser J, Mumtaz M, Muster W, Neilson L, Oprea TI, Patlewicz G, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz A-N, Ruiz P, Schilter B, Serafimova R, Simpson W, Stavitskaya L, Stidl R, Suarez-Rodriguez D, Szabo DT, Teasdale A, Trejo-Martin A, Valentin J-P, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Hasselgren C. 2018. In silico toxicology protocols. Regul Toxicol Pharmacol 96:1-17.

Rooney JP, Chorley B, Kleinstreuer N, Corton JC. 2018. Identification of androgen receptor modulators in a prostate cancer cell line microarray compendium. Toxicol Sci 166(1):146-162.
Featured in Toxicological Sciences' "Editor's Highlights" for that issue

Smirnova L, Kleinstreuer N, Corvi R, Levchenko A, Fitzpatrick SC, Hartung T. 2018. 3S - Systematic, systemic, and systems biology and toxicology. ALTEX 35(2):139-162.

Strickland J, Clippinger AJ, Brown J, Allen D, Jacobs A, Matheson J, Lowit A, Reinke EN, Johnson MS, Quinn MJ. 2018. Status of acute toxicity testing requirements and data uses by U.S. regulatory agencies. Reg Toxicol Pharmacol 94:183-196.

Thomas RS, Paules RS, Simeonov A, Fitzpatrick SC, Crofton KM, Casey WM, Mendrick DL. 2018. The US federal Tox21 program: a strategic and operational plan for continued leadership. ALTEX 35(2):163-168.

Bell SM, Phillips J, Sedykh A, Tandon A, Sprankle C, Morefield SQ, Shapiro A, Allen D, Shah R, Maull EA, Casey WM, Kleinstreuer NC. 2017. An integrated chemical environment to support 21st century toxicology. Environ Health Perspect. DOI:10.1289/EHP1759.

Braga R, Alves V, Muratov E, Strickland J, Kleinstreuer N, Tropsha A, Andrade C. 2017. Pred-Skin: a fast and reliable web app to assess skin sensitization effect of chemicals. J Chem Inf Model 57(5):1013-1017.

Browne P, Noyes PD, Casey WM, Dix DJ. 2017. Application of adverse outcome pathways to U.S. EPA's Endocrine Disruptor Screening Program. Environ Health Perspect. DOI:10.1289/EHP1304.

Ellis-Hutchings RG, Settivari RS, McCoy AT, Kleinstreuer N, Franzosa J, Knudsen TB, Carney EW. 2017. Embryonic vascular disruption adverse outcomes: Linking high-throughput signaling signatures with functional consequences. Reprod Toxicol 70:82-96.

Grego S, Dougherty DR, Alexander FJ, Auerbach SS, Berridge BR, Bittner ML, Casey W, Cooley PC, Dash A, Ferguson SS, Fennell TR, Hawkins BT, Hickey AJ, Kleensang A, Liebman MN, Martin F, Maull EA, Paragas F, Qiao G, Ramaiahgari S, Sumner SJ, Yoon M. 2017. Systems biology for organotypic cell cultures. ALTEX 34(2):301-310.

Hamm J, Sullivan K, Clippinger AJ, Strickland J, Bell S, Bhhatarai B, Blaauboer B, Casey W, Dorman D, Forsby A, Garcia-Reyero N, Gehen S, Graepel R, Hotchkiss J, Lowit A, Matheson J, Reaves E, Scarano L, Sprankle C, Tunkel J, Wilson D, Xia M, Zhu H, Allen D. 2017. Alternative approaches for identifying acute systemic toxicity: moving from research to regulatory testing. Toxicology In Vitro 41:245-259.

Kleinstreuer NC, Ceger P, Watt ED, Martin MT, Houck KA, Browne P, Thomas RS, Casey W, Dix D, Allen D, Sakamuru S, Xia M, Huang R, Judson RS. 2017. Development and validation of a computational model for androgen receptor activity. Chem Res Toxicol 30(4):946-964.
ACS Editors' Choice article: This designation, based on recommendations by the scientific editors of ACS journals around the world, makes this article open access, meaning it can viewed by anyone regardless of institutional affiliation or subscription status.

Lynch C, Sakamuru S, Huang R, Stavreva DA, Varticovski L, Hager GL, Judson RS, Houck KA, Kleinstreuer NC, Casey W, Paules RS, Simeonov A, Xia M. 2017. Identifying environmental chemicals as agonists of the androgen receptor by using a quantitative high-throughput screening platform. Toxicology 385:48-58.

Martin LA, Porter AG, Pelligrini VA, Schnatz PA, Jiang X, Kleinstreuer N, Hall JE, Verbiest S, Olmstead J, Fair R, Falorni A, Persani L, Rajkovic A, Mehta K, Nelson LM. 2017. A design thinking approach to primary ovarian insufficiency. Panminerva Med 59(1):15-32.

McCollum CW, de Vancells JC, Hans C, Vazquez-Chantada M, Kleinstreuer NC, Tal T, Knudsen T, Shah SS, Merchant FA, Finnell RH, Gustafsson J, Cabrera R, Bondesson M. 2017. Identification of vascular disruptor compounds by analysis in zebrafish embryos and mouse embryonic endothelial cells. Reprod Toxicol 70:60-69.

Mielke H, Strickland J, Jacobs MN, Mehta JM. 2017. Biometrical evaluation of the performance of the revised OECD Test Guideline 402 for assessing acute dermal toxicity. Regul Toxicol Pharmacol 89:26-39.

Miller MF, Goodson WH, Manjili MH, Kleinstreuer N, Bisson WH, Lowe L. 2017. Low-Dose Mixture Hypothesis of Carcinogenesis Workshop: Scientific Underpinnings and Research Recommendations. Environ Health Perspect 125:163-169.

Oki N, Leonard J, Nelms M, Bell S, Tan Y-M, Burgoon L, Edwards S. 2017. Linking environmental exposure to toxicity. In: Richardson RJ, Johnson DE, eds. Computational Systems Pharmacology and Toxicology. Cambridge, UK: Royal Society of Chemistry. DOI:10.1039/9781782623731.

Pamies D, Bal-Price A, Simeonov A, Tagle D, Allen D, Gerhold D, Yin D, Pistollato F, Inutsuka T, Sullivan K, Stacey G, Salem H, Leist M, Daneshian M, Vermuri MC, McFarland R, Coecke S, Fitzpatrick SC, Lakshmipathy U, Mack A, Wang WB, Daiju Y, Sekino Y, Kanda Y, Smirnova L, Hartung T. 2017. Good cell culture practice for stem cells and stem-cell-derived models. ALTEX 34(1):95-132.

Russo DP, Kim MT, Wang W, Pinolini D, Shende S, Strickland J, Hartung T, Zhu H. 2017. CIIPro: a new read-across portal to fill data gaps using public large-scale chemical and biological data. Bioinformatics 33(3):464-466.

Strickland J, Zang Q, Paris M, Lehmann DM, Allen D, Choksi N, Matheson J, Jacobs A, Casey W, Kleinstreuer N. 2017. Multivariate models for prediction of human skin sensitization hazard. J Appl Toxicol 37(3):347-360.

Tal T, Kilty C, Smith A, LaLone C, Kennedy B, Tennant A, McCollum CW, Bondesson M, Knudsen T, Padilla S, Kleinstreuer NC. 2017. Screening for angiogenic inhibitors in zebrafish to evaluate a predictive model for developmental vascular toxicity. Reprod Toxicol 70:70-81.

Zang Q, Mansouri K, Williams A, Judson R, Allen D, Casey W, Kleinstreuer N. 2017. In silico prediction of physicochemical properties of environmental chemicals using molecular fingerprints and machine learning. J Chem Inf Modeling 57:36-49.
Recognized as an NIEHS Intramural Paper of the Month, April 2017.

Zang Q, Paris M, Lehmann DM, Bell S, Kleinstreuer N, Allen D, Matheson J, Jacobs A, Casey W, Strickland J. 2017. Prediction of skin sensitization potency using machine learning approaches. J Appl Toxicol 37(7):792-805.

Alves V, Capuzzi S, Muratov E, Braga R, Thornton T, Fourches D, Strickland J, Kleinstreuer N, Andrade C, Tropsha A. 2016. QSAR models of human data can enrich or replace LLNA testing for human skin sensitization. Green Chemistry 18:6501-6515.

Arciniega J, Wagner L, Prymula R, Sebo P, Isbrucker R, Descampe B, Chapsal JM, Costanzo A, Hendriksen C, Hoonaker M, Nelson S, Lidster K, Casey W, Allen D. 2016. Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement. Report on an international workshop. Pharmeuropa Bio and Scientific Notes.

Ball N, Cronin MTD, Shen J, Adenuga MD, Blackburn K, Booth ED, Bouhifd M, Donley E, Egnash L, Freeman JJ, Hastings C, Juberg DR, Kleensang A, Kleinstreuer N, Kroese ED, Lee AC, Luechtefeld T, Maertens A, Marty S, Naciff JM, Palmer J, Pamies D, Penman M, Richarz A-N, Russo DP, Stuard SB, Patlewicz G, van Ravenzwaay B, Wu S, Zhu H, Hartung T. 2016. Toward good read-across practice (GRAP) guidance. ALTEX 33(2):149-66.

Casey WM. 2016. Advances in the development and validation of test methods in the United States. Toxicological Research 32:9-14.

Clippinger AJ, Ahluwalia A, Allen D, Bonner JC, Casey W, Castranova V, David RM, Halappnavar S, Hotchkiss JA, Jarabek AM, Maier M, Polk W, Rothen-Rutishauser B, Sayes CM, Sayre P, Sharma M, Stone V. 2016. Expert consensus on an in vitro approach to assess pulmonary fibrogenic potential of aerosolized nanomaterials. Arch Toxicol 90(7):1769-83.

Cote I, Andersen ME, Ankley GT, Barone S, Birnbaum LS, Boekelheide K, Bois FY, Burgoon LD, Chiu WA, Crawford-Brown D, Crofton KM, DeVito M, Devlin RB, Edwards SW, Guyton KZ, Hattis D, Judson RS, Knight D, Krewski D, Lambert J, Maull EA, Mendrick M, Paoli GM, Patel CJ, Perkins EJ, Poje G, Portier CJ, Rusyn I, Schulte PA, Simeonov A, Smith MT, Thayer KA, Thomas RS, Thomas R, Tice RR, Vandenberg JJ, Villeneuve DL, Wesselkamper S, Whelan M, Whittaker C, White R, Xia M, Yauk C, Zeise L, Zhao J, DeWoskin RS. 2016. The Next Generation of Risk Assessment multiyear study — highlights of findings, applications to risk assessment and future directions. Environ Health Perspect 124(111):1671-1682.

El-Masri H, Kleinstreuer N, Hines RN, Adams L, Tal T, Isaacs K, Wetmore B, Tan Y-M. 2016. Integration of life-stage physiologically based pharmacokinetic (PBPK) models with adverse outcome pathways (AOPs) and environmental exposure models to screen for environmental hazards. Toxicol Sci 152(1):230-43.

Griesinger C, Desprez B, Coecke S, Casey W, Zuang V. 2016. Validation of alternative in vitro methods to animal testing: concepts, challenges, processes and tools. Adv Exp Med Biol 856:65-132.

Judson R, Houck K, Martin M, Richard AM, Knudsen TB, Shah I, Little S, Wambaugh J, Setzer RW, Kothiya P, Phuong J, Filer D, Smith D, Reif D, Rotroff D, Kleinstreuer N, Sipes N, Xia M, Huang R, Crofton K, Thomas RS. 2016. Analysis of the effects of cell stress and cytotoxicity on in vitro assay activity across a diverse chemical and assay space. Toxicol Sci 152(2):323-39.

Kleinstreuer NC, Ceger P, Allen DG, Strickland J, Chang X, Hamm JT, Casey WM. 2016. A curated database of rodent uterotrophic bioactivity. Environ Health Perspect 124(5):556-62.
Link to Web page with database

Kleinstreuer NC, Sullivan K, Allen D, Edwards S, Mendrick DL, Embry M, Matheson J, Rowlands JC, Munn S, Maull E, Casey W. 2016. Adverse Outcome Pathways: From Research to Regulation. Scientific workshop report. Reg Toxicol Pharmacol 76:39-50.

Mansouri K, Abdelaziz A, Rybacka A, Roncaglioni A, Tropsha A, Varnek A, Zakharov A, Worth A, Richard AM, Grulke CM, Trisciuzzi D, Fourches D, Horvath D, Benfenati E, Muratov E, Wedebye EB, Grisoni F, Mangiatordi GF, Incisivo GM, Hong H, Ng HW, Tetko IV, Balabin I, Kancherla J, Shen J, Burton J, Nicklaus M, Cassotti M, Nikolov NG, Nicolotti O, Andersson PL, Zang Q, Politi R, Beger RD, Todeschini R, Huang R, Farag S, Rosenberg SA, Slavov S, Hu X, Judson RS. 2016. CERAPP: Collaborative Estrogen Receptor Activity Prediction Project. Environ Health Perspect 124(7):1023-33.

Oki NO, Nelms MD, Bell SM, Mortensen HM, Edwards SW. 2016. Accelerating adverse outcome pathway development using publicly available data sources. Curr Environ Health Rep 3:53-63.

Planchart A, Mattingly CJ, Allen D, Ceger P, Casey W, Hinton D, Kanungo J, Kullman SW, Tal T, Bondesson M, Burgess SM, Sullivan C, Kim C, Behl M, Padilla S, Reif DM, Tanguay RL, Hamm J. 2016. Advancing toxicology research using in vivo high throughput toxicology with small fish models. ALTEX 33(4):435-452.
Recognized as an NIEHS Intramural Paper of the Month, September 2016

Polk WW, Sharma M, Sayes CM, Hotchkiss JA, Clippinger AJ. 2016. Aerosol generation and characterization of multi-walled carbon nanotubes exposed to cells cultured at the air-liquid interface. Part Fibre Toxicol 13(1):20.

Strickland J, Zang Q, Kleinstreuer N, Paris M, Lehmann DM, Choksi N, Matheson J, Jacobs A, Lowit A, Allen D, Casey W. 2016. Integrated decision strategies for skin sensitization hazard. J Appl Toxicol 36(9):1150-62.
Recognized as an NIEHS Intramural Paper of the Month, October 2016

Wagner L, Isbrucker R, Locht C, Arciniega J, Costanzo A, McFarland R, Oh H, Hoonakker M, Descamps J, Andersen SR, Gupta RK, Markey K, Chapsal JM, Lidster K, Casey W, Allen D. 2016. In search of acceptable alternatives to the murine histamine sensitsation test (HIST): what is possible and practical? Pharmeur Bio Sci Notes 2016:151-170.

Zhu H, Bouhifd M, Kleinstreuer N, Kroese ED, Liu Z, Luechtefeld T, Pamies D, Shen J, Strauss V, Wu S, Hartung T. 2016. Supporting read-across using biological data. ALTEX 33(2):167-82.

Alves VM, Muratov E, Fourches D, Strickland J, Kleinstreuer N, Andrade CH, Tropsha A. 2015. Predicting chemically-induced skin reactions. Part I: QSAR models of skin sensitization and their application to identify potentially hazardous compounds. Toxicol Appl Pharmacol 284(2):262-272.

Alves VM, Muratov E, Fourches D, Strickland J, Kleinstreuer N, Andrade CH, Tropsha A. 2015. Predicting chemically-induced skin reactions. Part II: QSAR models of skin permeability and the relationships between skin permeability and skin sensitization. Toxicol Appl Pharmacol 284(2):273-280.

Browne P, Judson R, Casey W, Kleinstreuer N, Thomas R. 2015. Screening chemicals for estrogen receptor bioactivity using a computational model. Environ Sci Technol 49(14):8804-8814

Casey W, Jacobs A, Maull E, Matheson J, Clarke C, Lowit A. 2015. A new path forward: the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). J Am Assoc Lab Anim Sci 54(2): 170-173.

Ceger P, Allen D, Huang R, Xia M, Casey W. 2015. Performance of the BG1Luc ER TA Method in a qHTS Format. ALTEX 32(4): 287-296 .

Goodson WH, Lowe L, Carpenter DO, (107 other authors), Kleinstreuer N, (60 other authors), Luqmani Y, Chen Z, Hu Z. 2015. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: the challenge ahead. Carcinogenesis 36(Suppl 1):S254-S296.

Hu Z, Brooks SA, Dormoy V, (24 other authors), Lowe L, Jensen L, Bisson WH, Kleinstreuer N. 2015. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: focus on the cancer hallmark of tumor angiogenesis. Carcinogenesis 36(Suppl 1):S184-S202.

Jaworska JS, Natsch A, Ryan C, Strickland J, Ashikaga T, Miyazawa M. 2015. Bayesian integrated testing strategy (ITS) for skin sensitization potency assessment: a decision support system for quantitative weight of evidence and adaptive testing strategy. Archives of Toxicology 89:2355-2383.

McKim J, Bahadori T, Casey W, Paules R, Thomas R. 2015. Changing the paradigm of toxicity testing from observational to predictive: an update on two global screening initiatives. Applied In Vitro Toxicology 1(2):91-98.

Rovida C, Alepee N, Api AM, Basketter DA, Bois FY, Caloni F, Corsini E, Daneshian M, Eskes C, Ezendam J, Fuchs H, Hayden P, Hegele-Hartung C, Hoffmann S, Hubesch B, Jacobs MN, Jaworska J, Kleensang A, Kleinstreuer N, Lalko J, Landsiedel R, Lebreux F, Luechtefeld T, Locatelli M, Mehling A, Natsch A, Pitchford JW, Prater D, Prieto P, Schepky A, Schüürmann G, Smirnova L, Toole C, van Vliet E, Weisensee D, Hartung T. 2015. Integrated Testing Strategies (ITS) for safety assessment. ALTEX 32(1):25-40.

Sewell F, Ragan I, Marczylo T, Anderson B, Braun A, Casey W, Dennison N, Griffiths D, Guest R, Holmes T, van Huygevoort T, Indans I, Kenny T, Kojima H, Lee K, Prieto P, Smith P, Smedley J, Stokes WS, Wnorowski G, Horgan G. 2015. A global initiative to refine acute inhalation studies through the use of 'evident toxicity' as an endpoint: Towards adoption of the fixed concentration procedure. Regul Toxicol Pharmacol 73(3):770-9.

Chang X, Kleinstreuer N, Ceger P, Hsieh J-H, Allen D, Casey W. 2014. Application of reverse dosimetry to compare in vitro and in vivo estrogen receptor activity. Applied In Vitro Toxicology 1(1):33-44.

Huang R, Sakamuru S, Martin MT, Reif DM, Judson RS, Houck KA, Casey W, Hsieh J-H, Shockley KR, Ceger P, Fostel J, Witt KL, Tong W, Rotroff DM, Zhao T, Shinn P, Simeonov A, Dix DJ, Austin CP, Kavlock RJ, Tice RR, Xia M. 2014. Profiling of the Tox21 10K compound library for agonists and antagonists of the estrogen receptor alpha signaling pathway. Nature Scientific Reports doi:10.1038/srep05664.

Hsu C-W, Zhao J, Huang R, Hsieh J-H, Hamm J, Chang X, Houck K, Xia M. 2014. Quantitative high-throughput profiling of environmental chemicals and drugs that modulate farnesoid X receptor. Nature Scientific Reports doi:10.1038/srep06437.

Isbrucker R, Arciniega J, McFarland R, Chapsal J-M, Xing D, Bache C, Nelson S, Costanzo A, Hoonakker M, Castiaux A, Halder M, Casey W, Johnson N, Jones B, Doelling V, Sprankle C, Rinckel L, Stokes W. 2014. Report on the International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward. Biologicals 42(2):114-122.

Kleinstreuer N, Yang J, Berg EL, Knudsen TB, Richard AM, Martin MT, Reif DM, Judson RS, Polokoff M, Dix DJ, Kavlock RJ, Houck KA. 2014. Phenotypic screening of the ToxCast chemical library to classify toxic and therapeutic mechanisms. Nature Biotechnology 32:583-591.
Winner, 2015 Best Publication Award, Society of Toxicology Biotechnology Specialty Section

McKim F, Goldberg A, Kleinstreuer N, Busquet F, Andersen M. 2014. A vision of toxicity testing in the 21st century. Applied In Vitro Toxicology 1(1): 5-10.

Pirone JR, Smith M, Kleinstreuer NC, Burns TA, Strickland J, Dancik Y, Morris R, Rinckel LA, Casey W, Jaworska JA. 2014. Open source software implementation of an integrated testing strategy for skin sensitization potency based on a Bayesian network. ALTEX 31:336-340.

Tal TL, McCollum CW, Harris P, Padilla S, Kleinstreuer NC, Bondesson M, Knudsen TK, Hemmer MK. 2014 Immediate and long-term consequences of vascular toxicity during development using a quantitative vascular disruption assay in zebrafish. Reproductive Toxicology 48:51-61.

View Report on the International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward(published in 2013 in Biologicals)

Alt DP, Wilson-Welder J. 2013. Expansion of the in vitro assay for Leptospira potency testing to other serovars: Case study with Leptospira Hardjo. Biologicals 41:323-324.

Balks E, Gyra H, Kobe B, Cussler K, Werner E. 2013. Development and validation of a serological potency test for the release of Leptospira vaccines — Requirements in the European Union. Biologicals 41:325-329.

Birnbaum L. 2013. 15 years out: Reinventing ICCVAM. Environ Health Perspect 121:a40-a40.

Bruckner L. 2013. European regulatory framework and practices for veterinary Leptospira vaccine potency testing. Biologicals 41:303-304.

Draayer HA, Bruckner L, de la Pena-Moctezuma A, Srinivas G. 2013. International regulatory requirements for Leptospira vaccine potency testing. Roundtable: Current requirements and opportunity for harmonization. Biologicals 41:305-307.

Juberg DR, Borghoff SJ, Becker RA, Casey W, Hartung T, Holsapple MP, Marty MS, Mihaich EM, Van Der Kraak G, Wade MG, Willett CE, Andersen ME, Borgert CJ, Coady KK, Dourson ML, Fowle JR, Gray LE, Lamb JC, Ortego LS, Schug TT, Toole CM, Zorrilla LM, Kroner OL, Patterson J, Rinckel LA, Jones BR. 2013. t4 workshop report: Lessons Learned, Challenges, and Opportunities: The U.S. Endocrine Disruptor Screening Program. ALTEX 31(1), 63-78.

Klaasen HLBM, van der Veen M, Molkenboer MJCH, Bruderer U. 2013. Development of Leptospira in vitro potency assays: EU/industry experience and perspectives. Biologicals 41:315-322.

Kolle SN, DA Basketter, S Casati, WS Stokes, J Strickland, B van Ravenzwaay, HW Vohr and R Landsiedel. 2013. Performance standards and alternative assays: Practical insights from skin sensitization. Regul. Toxicol. Pharmacol. 65 (2): pp. 278-285 .

Ruby KW, Srinivas GB. 2013. Development of in vitro assays for measuring the relative potency of leptospiral bacterins containing serogroups canicola, grippotyphosa, icterohaemorrhagiae, and pomona. Biologicals 41:308-314.

Srinivas GB, Walker A, Rippke B. 2013. USDA regulatory guidelines and practices for veterinary Leptospira vaccine potency testing. Biologicals 41:298-302.

Stirling C, Novokova V. 2013. Product-specific validation of a serological potency test for release of Leptospira vaccines in the European Union. Biologicals 41:330-331.

Stokes W, Srinivas G, McFarland R, Kulpa-Eddy J, Casey W, Walker A, Draayer H, Sebring R, Brown K, Balks E, Stirling C, Klaasen E, Hill R, Rippke B, Ruby K, Alt D, Mukhopadhyay S, Kojima H, Johnson N, Rinckel L, Doelling V, Jones B. 2013. Report on the International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward. Biologicals 41:279-294.

Guerra M. 2013. Leptospirosis: Public health perspectives. Biologicals 41:295-297.

Walker A, Srinivas GB. 2013. Opportunities and strategies to further reduce animal use for Leptospira vaccine potency testing. Biologicals 41:332-337.

Casey W, Ceger P, Allen D, Strickland J, Hamm J, Paris M, Stokes W. 2012. BG1Luc ER TA Test Method: Results of an International Validation Study and Proposed Performance Standards. In: Proceedings of the 8th World Congress on Alternatives and Animal Use in the Life Sciences. ALTEX Proceedings 1: 105-107.

Stokes W, McFarland R, Kulpa-Eddy J, Gatewood D, Levis R, Halder M, Pulle G, Kojima H, Casey W, Gaydamaka A, Miller T, Brown K, Lewis C, Chapsal J-M, Bruckner L, Gairola S, Kamphuis E, Rupprecht C, Wunderli P, McElhinney L, De Mattia F, Gamoh K, Hill R, Reed D, Doelling V, Johnson N, Allen D, Rinckel L, Jones B. 2012. Report on the International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward. Biologicals 40: 369-381.
View on Biologicals website

Stokes WS, Strickland J, Casey W. 2012. Validation of the 21st century toxicology toolbox: Challenges, opportunities, and the way forward. In: Proceedings of the 8th World Congress on Alternatives and Animal Use in the Life Sciences. ALTEX Proceedings 1: 323-328.

(published in 2011 in Procedia in Vaccinology)
View Report on the International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing

Arciniega JL, Corvette L, Hsu H, Lynn F, Romani T, Dobbelaer R. 2011. Target alternative vaccine safety testing strategies for pertussis toxin. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 248-260.

Arciniega JL, Dominguez-Castillo RI. 2011. Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 213-220.

Casey W, Schmitt M, McFarland R, Isbrucker R, Levis R, Arciniega JL, Descamps J, Finn T, Hendriksen C, Horiuchi Y, Keller J, Kojima H, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D. 2011. Improving animal welfare and reducing animal use for human vaccine potency testing: state-of-the-science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 33-46.

Haseman JK, Allen DG, Lipscomb EA, Truax JF, Stokes WS. 2011. Using fewer animals to identify chemical eye hazards: revised criteria necessary to maintain equivalent hazard classification. Regul Toxicol Pharmacol 61(1):98-104.

Haseman JK, Strickland J, Allen D, Salicru E, Paris M, Tice RR, Stokes WS. 2011. Safety assessment of allergic contact dermatitis hazards: An analysis supporting reduced animal use for the murine local lymph node assay. Regulatory Toxicology and Pharmacology. 59:191-196.

Isbrucker R, Levis R, Casey W, McFarland R, Schmitt M, Arciniega JL, Descamps J, Finn T, Hendriksen C, Horiuchi Y, Keller J, Kojima H, Sesardic D, Stickings P, Johnson NW, Allen D. 2011. Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 47-59.

Kulpa-Eddy J, Dusek D. 2011. Application of the consistency approach to reduce animal use in vaccine potency testing. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 232-235.

Kulpa-Eddy J, Srinivas G. 2011. Approaches to reducing animal numbers in vaccine potency testing. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 227-231.

Kulpa-Eddy J, Srinivas G, Halder M, Brown K, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B, Stokes WS. 2011. Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 106-119.

Kulpa-Eddy J, Srinivas G, Halder M, Hill R, Brown K, Roth J, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B, Stokes WS. 2011. Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 60-83.

McFarland R, Verthelyi D, Casey W, Arciniega JL, Isbrucker R, Schmitt M, Finn T, Descamps J, Horiuchi Y, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D. 2011. Non-animal replacement methods for human vaccine potency testing: state of the science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 16-32.

Stokes WS. 2011. Best practices for the use of animals in toxicological research and testing. Ann N Y Acad Sci 1245(1):17-20.

Stokes WS, Brown K, Kulpa-Eddy J, Srinivas G, Halder M, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B. 2011. Improving animal welfare and reducing animal use for veterinary vaccine potency testing: state-of-the-science and future directions. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 84-105.

Stokes WS, Kulpa-Eddy J, McFarland R. 2011. The International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: introduction and summary. In: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions (Kulpa-Eddy J, McFarland R, Stokes WS, eds). Procedia Vaccinol 5: 1-15

Birnbaum L, Stokes W. Safety Testing: Moving Toward Alternative Methods [Editorial]. Environ Health Perspect 118(1):A12-A13.

• Letter to the EHP editor (May 2010 issue) commenting on the editorial and response from Drs. Birnbaum and Stokes

Scott L, Eskes C, Hoffmann S, Adriaens E, Alepée N, Bufo M, Clothier R, Facchini D, Faller C, Guest R, Harbell J, Hartung T, Kamp H, Varlet BL, Meloni M, McNamee P, Osborne R, Pape W, Pfannenbecker U, Prinsen M, Seaman C, Spielmann H, Stokes W, Trouba K, Berghe CV, Goethem FV, Vassallo M, Vinardell P, Zuang V. 2010. A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol In Vitro 24(1):1-9.

Stokes WS, Wind M. 2010. Recent progress and future directions at ICCVAM: validation and regulatory acceptance of alternative test methods that reduce, refine, and replace animal use. ALTEX 27 (Special Issue):2-13.

Stokes WS, Wind M. 2010. Validation of innovative technologies and strategies for regulatory safety assessment methods: challenges and opportunities. ALTEX 27 (Special Issue):87-95.

Stokes WS, Wind M. 2010. NICEATM and ICCVAM participation in the International Cooperation on Alternative Test Methods. ALTEX 27 (Special Issue):211-219.

Wind M, Stokes WS. 2010. Developing performance standards to expedite validation of innovative and improved test methods. ALTEX 27 (Special Issue):97-102.

Wind M, Stokes WS. 2010. The International Cooperation on Alternative Test Methods (ICATM). ALTEX 27 (Special Issue):207-210.

Contact NICEATM for information on publications prior to 2010