药物BCS分类系统.ppt

Pharmaceutical Development with Focus on Paediatric formulations;Biopharmaceutical Classification System (BCS);Biopharmaceutical Classification System (BCS);What is the key for multisource (generic) pharmaceutical products?;Therapeutic interchangeability: prerequisites;Options to show therapeutic interchangeability of multisource pharmaceutical products (MPP);The in vitro approach refers to the Biopharmaceutics Classification System (BCS) ;In Vitro Approaches/Biowaiver options;Principles;A theoretical risk assessment is mandatory to minimize risk for falsely waiving a necessary in vivo st