Chemistry Specifications
Chemistry is the foundation of toxicology, which is why chemistry support services are vital to NTP's mission of providing world-class and cutting-edge toxicology research. Chemistry Specifications documents describe the requirements for chemistry activities performed to support NTP toxicology research, as well as include detailed information for Chemistry Services Contractors.
Services are divided into two broad categories of Project Management and Technical Support. Project Management includes: staffing and facility requirements, quality assurance, and animal care. Technical Support is divided into seven categories:
- Logistics and Handling, which covers chemical receipt, storage, and shipment
- Characterization, which covers determining the identity and purity of a chemical before it is used in a study
- Formulations, which covers formulating a chemical with a vehicle and analyzing the subsequent dose mixture
- Biosample Analysis, which covers the analysis of any biological matrix for a test chemical, metabolite, or marker compound
- Animal Studies, which includes palatability, toxicokinetic, and absorption, distribution, metabolism, and excretion (ADME) studies
- Special Studies, which are combinations or modifications of defined activities in one or more of the technical categories
- High-throughput toxicology screening studies (HTS) support
The table of contents below provides links to each section of the requirements described above along with Health and Safety and Reporting requirements.
Table of Contents
- Section 1. Project Management (updated August 2017)
- Section 2. Requirements
- Requirement 1. Logistics and Handling (updated August 2016)
- Requirement 2. Characterization (updated August 2016)
- Requirement 3. Formulations (updated August 2017)
- Appendix 3.1 Vehicle Analysis of Ethanol (updated September 2013)
- Requirement 4. Biosample Analysis (updated August 2017)
- Requirement 5. Animal Studies (updated February 2018)
- Requirement 6. Special Studies (updated August 2016)
- Requirement 7. HTS Support (updated August 2016)
- Appendix 7.1 HTS Plate Maps and Structure Files (updated September 2013)
- Section 3. Health and Safety (updated September 2013)
- Section 4. Reporting Requirements (updated August 2017)
- Appendix 4.1 Report Formatting Requirements (updated August 2016)
- Appendix 4.2 Data Submission Requirements (updated August 2016)