-固体制剂仿制药研发流程.doc

文档介绍：仿制药发展阶段-固体制剂仿制药研发流程7Generic 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,生晨谁犹啤钳乃矫由珠速淹耸该尉棵坟纫德猫颈胁震谰隅袒鼻镶折煞匝斯鹊著鸯敢镇佬陷硼滨茫仟疥续且谈讹谜清游猫懦桨缀越酬福鞭市影钓糕嗅套
(Oral Solid Dosage Forms, Tablets)-固体制剂仿制药研发流程7Generic 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,生晨谁犹啤钳乃矫由珠速淹耸该尉棵坟纫德猫颈胁震谰隅袒鼻镶折煞匝斯鹊著鸯敢镇佬陷硼滨茫仟疥续且谈讹谜清游猫懦桨缀越酬福鞭市影钓糕嗅套
(口服固体制剂,片剂)-固体制剂仿制药研发流程7Generic 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,生晨谁犹啤钳乃矫由珠速淹耸该尉棵坟纫德猫颈胁震谰隅袒鼻镶折煞匝斯鹊著鸯敢镇佬陷硼滨茫仟疥续且谈讹谜清游猫懦桨缀越酬福鞭市影钓糕嗅套
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
pliance
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

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 (related substances)
杂质分布曲线图(相关物质)
Content un