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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 Program Management and Technical Support. Program Management includes: staffing and facility requirements, quality assurance, and animal care. Technical Support is divided into seven categories:

  1. Logistics and Handling, which covers chemical receipt, storage, and shipment
  2. Characterization, which covers determining the identity and purity of a chemical before it is used in a study
  3. Formulation, which covers formulating a chemical with a vehicle and analyzing the subsequent dose mixture
  4. Biosample Analysis, which covers the analysis of any biological matrix for a test chemical, metabolite, or marker compound
  5. Animal Studies, which includes palatability, toxicokinetic, and absorption, distribution, metabolism, and excretion (ADME) studies
  6. Special Studies, which are combinations or modifications of defined activities in one or more of the technical categories
  7. 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