IGF::OT::IGF "Rodent Pharmacokinetic and Brain Level Determination"

IGF::OT::IGF“啮齿动物药代动力学和脑水平测定”

• 批准号: 8759147
• 负责人: ROSE HOOD
• 金额: $ 9.99万
• 依托单位: SOUTHERN RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-13 至 2014-09-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8759147
• 关键词: Acute; Biological; Biological Assay; Brain; Clinical; Contractor; Contracts; Cytochrome P450; Development; Dose; Drug Kinetics; Evaluation; Hepatotoxicity; In Vitro; Investigational New Drug Application; Lead; Liquid substance; Metabolic; Permeability; Pharmaceutical Preparations; Pharmacology and Toxicology; Plasma Proteins; Protein Binding; Protocols documentation; Research Personnel; Rodent; Route; Solutions; Testing; Tissues; Toxic effect; United States National Institutes of Health; Validation; analytical method; drug development; genotoxicity; in vivo; pre-clinical; research clinical testing

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.

1.药理学和毒理学机构（PTNP）。如本工作说明书所述，PTNP承包商将提供所有临床前药理学和毒理学试验，以告知电极导线优化和临床候选药物的选择，以及FDA新药研究（IND）申请所需的试验，以支持化合物的临床评价。 2.承包商应根据承包商开发并经NIH项目官员批准的每种制剂的完整方案要求，并在适当时符合FDA的要求，进行非GLP和GLP毒理学和药理学研究。 3.