IGF::OT::IGF: Non-Clinical ADME Studies. N01DA-16-8931.

IGF::OT::IGF：非临床 ADME 研究。

• 批准号: 9430375
• 负责人: LALITHA IVER
• 金额: $ 12.01万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-19 至 2021-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9430375
• 关键词: Animals; Biological; Biological Assay; Biological Availability; Contractor; Data; Data Files; In Vitro; Investigational Drugs; Liquid substance; Metabolism; Methods; National Institute of Drug Abuse; Pharmaceutical Preparations; Protocols documentation; Regulation; Reporting; Research Personnel; Secure; United States Food and Drug Administration; absorption; analytical method; electronic data; novel therapeutics

The data generated will be used by the National Institute on Drug Abuse (NIDA) and NIDA sponsored investigators for submissions to the Food and Drug Administration (FDA) in support of Investigational New Drugs (INDs) and New Drug Applications (NDAs). The Contractor will perform in accordance with pertinent Food and Drug Administration (FDA) guidance and regulations.

生成的数据将由国家药物滥用研究所（NIDA）和NIDA赞助的研究人员用于向食品和药物管理局（FDA）提交支持研究性新药（INDs）和新药申请（NDAs）的材料。承包商将按照美国食品和药物管理局（FDA）的相关指导和法规执行。