药物研发与生产过程中质量控制新理念和新技术资料.pptVIP

* * * * * * 最新进展 * Biopharmaceutics Classification System BCS (Amidon et al, 1995) Human Genome Project Completion (2003) Better understanding of Drug Transporters and Metabolizing Enzymes- availability of in vitro systems Biopharmaceutics Drug Disposition Classification System BDDCS (Benet et al, 2006) 生物等效性与生物利用度 * BCS是什么? 渗透性与溶解度的分类 * 生物药剂类型 溶解度 渗透性 I High High II Low High III High Low IV Low Low 近端人类胃肠道模拟液汁 模拟胃液 模拟肠汁 Fasted Fed (FeSSGF) Fasted Fed (FaSSGF) Early Middle Late (FaSSIF) (FeSSIF) Na taurocholate NaCl NaCl NaCl Na taurocholate Na taurocholate Lecithin Milk/buffer HoAc H3PO4