National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/niceatm-pubs

Publications About NICEATM and ICCVAM Activities in Scientific Journals

2014

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 [published online ahead of print 11 July 2014]. Nature Scientific Reports.

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.

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.

2013

View Report on the International Workshop on Alternative Methods for 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.

 

2012

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.

2011

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

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

2010

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

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

NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.