AdditionalConsiderations附加事項.pptVIP

Additional Considerations/附加事项 Training Program on Pharmaceutical Quality, Good Manufacturing Practice and Bioequivalence 药物质量，生产操作规范及生物等效性培训大纲 Jiaxing, Zhejiang, China 5 – 9 November 2007 Dr. Henrike Potthast (h.potthast@bfarm.de) temporary consultant to WHO Additional Considerations/附加事项 Use of metabolite data in BE assessment 生物等效性评估中代谢物数据的应用 Stereochemistry and BE assessment 立体化学与生物等效性评估 Use of urine data in BE assessment 生物等效性评估中尿液数据的应用 Additional Considerations /附加事项 “…Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation.” 生物等效性的重点就是研究药物活性成分从制剂中释放并经吸收进入全身循环的程度和速度是否相同。 [WHO Working Document Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability November 2005] Additional Considerations /附加事项 Bioavailability – rate and extent at which a drug substance... becomes available in the general system (product characteristic!) 生物利用度——指一个药物进入整个系统达到有效作用时的速率和程度…（产品特性） Bioequivalence – equivalent bioavailability within pre-set acceptance ranges 生物等效性——在即定的接受限度内生物利用度相同 Pharmaceutical equivalence ? Bioequivalence 药学等效性 ? 生物等效性 Bioequivalence ? Therapeutic equivalence 生物等效性 ? 治疗等效 Additional Considerations /附加事项 Metabolites in BE assessment 生物等效性评估中的代谢物 Examples 例子 Additional Considerations /附加事项 Additional Considerations /附加事项 Additional Considerations /附加事项 ? ?……Concentration-time profile of the parent drug is more sensitive to changes in formulation performance than a metabolite, which is more reflective of metabolite formation, distribution and elimination….“ 母体药物的药物浓度-时间曲线相较于代谢物更易受到剂型改变的影响；而代谢物的药物浓度-时间曲线更多反映的是代谢物形成，分布及消除… [WHO Working Document Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability November 2005] Additional Considerations /附加事项 Use of metabolite data in BE assessment if/when 当或如果发生以下情况时，可以在生物等效性