1. Pharmacology and toxicology facilities (PTNPs). As detailed in this SOW, the PTNP Contractor(s) will provide all preclinical pharmacology and toxicology testing needed to inform lead optimization and the selection of a clinical candidate, and testing required for an Investigational New Drug (IND) application for the FDA to support clinical evaluation of the compound. 2. The Contractor shall conduct both non-GLP and GLP toxicology and pharmacology studies in accordance with the complete protocol requirements for each agent developed by the Contractor and approved by the NIH Project Officer, and, when appropriate, in compliance with the requirements of the FDA. 3.
