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

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。承包商应编制研究方案，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，并编制研究报告。数据/报告将提交给FDA，以支持IND（研究性新药）和NDA（新药申请）。

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).