关于抗结核药药品的质量.pptVIP

Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November 2007 1 | PQ 项目 优先基本用药 关于抗结核药药品的质量， GMP 和生物生效性 的培训项目 Jiaxing Peoples Republic of China 5 – 9 November 2007 Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November 2007 2 | 专题讨论会 药品的质量和交换性的评估 生物等效性的常规要求 讲师： Drs. J. Welink Senior pharmacokineticist Medicines Evaluation Board, NL WHO adviser E-mail: j.welink@cbg-meb.nl Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November 2007 3 | 指导性文件 * /prequal * Guideline on generics - Annex 7 (Multisource (generic) pharm. products: guidelines on registration requirements to establish interchangeability) - EU “Note for Guidance on the Investigation of Bioavailability and Bioequivalence” CPMP/EWP/QWP/1401/98 ” - FDA “Guidance for Industry: “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations” (Oct. 2000) – and related guidances” - CN “Guidance for Industry; Conduct and analysis of bioavailability and bioequivalence studies – Part A: Oral dosage formulations used for systemic effects (1992) Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November 2007 4 | 生物等效性 生物利用度是指药物活性成分或治疗成分 由制剂释放经吸收进入体内并在靶位达到 有效浓度的程度和速度 生物等效性 = 符合预定标准的吸收程度和速度的生物利用度 药品特性 Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November 2007 5 | 生物等效性 对照品 测试品 药学等效性 产品 可能存在的差异 药物微粒尺寸， … 辅料 生产工艺 设备 生产场所 批量 … 备有证明文件的生物等效性 = 治疗等效性（ Therapeutic Equivalence ） （注意：通常具有相同的溶出度标准） Evaluation of quality and interchangeability of medicinal products - WHO Training workshop / 5-9 November 2007 6 | 生物等效性 药动学研究 临床研究 体外方法 建立等效性的不同方法 标准：体内 生物等效性研究 Evaluation of quality and intercha