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[摘要]
参考国际上的相关指导原则,对《中国药典》2015年版药物制剂生物利用度和生物等效性指导原则提出了修改草案。包括前言,常释制剂生物等效性试验的设计、实施和评价,调释制剂和透皮吸收制剂的生物等效性试验,试验报告,与生物等效性试验相关的体外溶出度检查,对不同剂型的生物等效性要求,以及基于生物药剂学分类系统的生物豁免。与现行药典指导原则相比,把生物样品定量分析方法的内容分离出去,对试验药品的规格、参比制剂选取、测试原形药物还是代谢物、高变异性药品生物等效性等提供了新的建议,强调溶出度实验的意义,并引入了生物试验豁免的相关内容。
[Key word]
[Abstract]
This is the draft version for the Guidance on the Bioavailability and Bioequivalence Study of Drug Products in China Pharmacopoeia, 2015 Edition. It includes the introduction, design, conduct and evaluation of bioequivalence studies for immediate release formulations with systemic action, study report, bioequivalence study requirements for different dosage forms, and biowaiver based on biopharmaceutics classification system (BCS). In comparison to the current guidance, the bioanalytical method is separated as a discrete guidance, and new recommendations are provided for the selection of reference product, strength to be investigated, parent compound or metabolites, and bioequivalence of highly variable drugs. The importance of in vitro dissolution tests is highlighted and the BCS-based biowaiver is introduced.
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