固体制剂仿制药研发流程.doc

PAGE Generic Drug Product Development Stages 仿制药发展阶段 (Oral Solid Dosage Forms, Tablets) （口服固体制剂，片剂） Stage Chemistry, Manufacturing Controls in Oral Solid Dosage Form Development 口服固体制剂发展中的化学特性，生产和控制 CGMP Compliance to Meet Regulatory Requirements 满足法规要求的CGMP规范 1 Drug Packaging Insert Study to obtain basic information about RLD, such as 通过对对照药物的包材以内成分的分析，获取有关该对照药物的基本信息 Components in the formulation处方成份 BE information生物等效性信息 Etc.其它 2 Reverse Engineering Study, including evaluation of three different lots of RLD for: 根据前述研究采用倒推法研究制剂工艺，包括对叁批不同批次对照药物的评估 Potency/purity 效价/纯度 Impurity profile (