精选优质文档-倾情为你奉上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）StageChemistry, Manufacturing & Controlsin 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 Complianceto Meet Regulatory Requirements满足法规要求的CGMP规范1Drug 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
