AdditionalConsiderations附加事项.ppt

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 pr