PHARMACOKINETIC ANALYSIS RESOURCE CENTER

药代动力学分析资源中心

• 批准号: 6130166
• 负责人: KARL E PEACE
• 金额: $ 35.39万
• 依托单位: BIOPHARMACEUTICAL RESEARCH CONSULTANTS
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-23 至 2000-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6130166
• 关键词: drug addiction antagonist; health science research support; pharmacokinetics

The Contractor shall serve as a pharmacokinetic resource in support of the pharmacokinetic (PK) and pharmacodynamic (PD) aspect of the medications development program. PK studies are carried out to determine the absorption and disposition of a drug in the body and PD studies are carried out to determine the pharmacological effects of a drug. PK and PD studies provide a means to determine the relationships among dose, plasma concentration and pharmacological effect. The PK and PD data provide a basis for the selection of promising medications for further clinical development and for the rational design of dosage regimens. Therefore, PK and PD studies are essential for the development of effective medications and are required in every phase of medication development. Pk and PD information of this sort is a requirement of the Food and Drug Administration (FDA) for the approval of new drugs. The Contractor shall prepare protocols, monitor studies to assure that pertinent FDA regulations are met, compile and edit data, conduct PK, PD and statistical analyses, and prepare reports. The data/report will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications).

承包商应充当药代动力学资源，以支持 药物的药代动力学（PK）和药效学（PD）方面 药物开发计划。 进行PK研究以确定吸收和处置 药物在体内的作用，进行PD研究以确定 药物的药理作用。PK和PD研究提供了一种方法， 确定剂量、血药浓度和 药理作用PK和PD数据为以下研究提供了依据： 选择有前景的药物进行进一步的临床开发， 合理设计给药方案。因此，PK和PD研究 对于开发有效的药物至关重要， 在药物开发的每个阶段都需要。PK和PD信息 这是食品和药物管理局（FDA）的要求 用于新药的审批 承包商应准备方案，监测研究，以确保 符合相关FDA法规，汇编和编辑数据，进行PK、PD 统计分析，并编写报告。数据/报告将 提交给FDA以支持IND（研究性新药）， 新药申请（New Drug Applications）