FY20. TO3. NIDA PHARMACOKINETIC ANALYSIS RESOURCE CENTER. NIDA REF. NO. N01DA-19-8947. PERIOD OF PERFORMANCE: 09/01/2020 TO 02/28/2022.

2020 财年。

• 批准号: 10286222
• 负责人: DAVID MALLOY
• 金额: $ 30.17万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2024-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10286222
• 关键词: Clinical; Clinical Pharmacology; Clinical Research; Contractor; Data; Data Reporting; Development; Drug Kinetics; Investigational Drugs; Monitor; National Institute of Drug Abuse; Performance; Pharmaceutical Preparations; Pharmacodynamics; Process; Protocols documentation; Regulation; Reporting; Resources; Statistical Data Interpretation; United States Food and Drug Administration; novel therapeutics; pharmacokinetics and pharmacodynamics

The Contractor shall serve as a pharmacokinetic resource in support of the pharmacokinetic (PK) and pharmacodynamics (PD) aspects of the medications development. The contractor will provide support to clinical pharmacology/pharmacokinetic studies including interaction studies. The Contractor shall prepare study protocols, monitor clinical studies to assure that pertinent Food and Drug Administration(FDA) regulations are met, manage and process clinical and pharmacokinetic data, conduct PK, PD, and statistical analyses, and prepare study reports. The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications).

承包商应作为药代动力学资源，支持药物开发的药代动力学 (PK) 和药效学 (PD) 方面。承包商将为临床药理学/药代动力学研究（包括相互作用研究）提供支持。承包商应制定研究方案、监测临床研究以确保符合相关食品药品监督管理局 (FDA) 法规、管理和处理临床和药代动力学数据、进行 PK、PD 和统计分析，并准备研究报告。数据/报告将提交给 FDA 以支持 IND（新药研究）和 NDA（新药申请）。