上海cmc培训生物利用和生物等效性在仿制药和新药申请中的法规要求.pptxVIP

Bioavailability and Bioequivalence Study in Generic and new Drug Applications生物利用度和生物等效性在仿制药和新药申请中的法规要求;Agenda议程;Bioavailability – defined生物利用度定义;Plasma Concentration Profile血药浓度时间曲线;Points to Consider – BA生物利用度PK指标;Approaches to Determining Bioequivalence (21 CFR 320.24)检测生物等效性试验的各种方法;Single-dose, two-way crossover, fasted Single-dose, two-way crossover, fed Alternatives Single-dose, parallel, fasted Long Half-Life (wash-out): Amiodarone, Etidronate Single-dose, replicate design Highly Variable Drugs Multiple-dose, two-way crossover, fasted Less Sensitive: Clozapine (Patient Trials);