IGF::OT::IGF "Pharmacology and Toxicology for Neurotherapeutics (PTNP)"

1.药理和毒理设施(PTNPs)。如本SOW中所述，PTNP承包商(S)将提供所有临床前药理学和毒理学测试，以便为线索优化和临床候选药物的选择提供信息，并为FDA提供研究性新药(IND)申请所需的测试，以支持化合物的临床评估。 2.承包商应根据承包商为每个试剂制定并经NIH项目官员批准的完整方案要求，并在适当情况下符合FDA的要求，进行非GLP和GLP毒理学和药理学研究。 3.承包商可能被要求从蓝图网络以外的调查人员那里支持本合同范围内的药物开发项目。

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. The Contractor may be required to support drug development projects within the scope of this contract from investigators outside of the Blueprint Network.