报批美国FDA仿制药研发与相关问题探讨何平.ppt
《报批美国FDA仿制药研发与相关问题探讨何平.ppt》由会员分享,可在线阅读,更多相关《报批美国FDA仿制药研发与相关问题探讨何平.ppt(41页珍藏版)》请在三一文库上搜索。
1、优秀精品课件文档资料,开发报批美国FDA的仿制药与相关问题探讨,上海复星普适医药科技有限公司 何平,内容提要,开发仿制药的重要性和机遇 开发仿制药的挑战 申报仿制药的分类 仿制药研发团队 仿制药的研发过程 QbD在制剂开发中怎么体现 研发(高难)仿制药的一些体会:案例研究,开发仿制药的重要性,新药与仿制药-NDA and ANDA 开发仿制药与我国药物研发的海外战略,药物制剂 目标主流市场,开发仿制药的挑战性,开发仿制药更具挑战性 药物制剂 专利 仿制药的竞争 仿制药厂之间的竞争 由品牌药转成仿制药,仿制药竞争的方式 HOW TO COMPETE,Cost-IR Product Raw Mat
2、erials Process Finished Product Technology-Modified Release Products,申报(仿制)新药的分类,规范市场(FDA) 1。P-I 2。P-II 3。P-III 4。P-IV (1st to file),中国市场(sFDA) 1类 2类 3类 4类 5类 6类,仿制药研发团队 CONCEPT-1 BUILD UP A TEAM,REGULATORY,DRUG DELIVERY SYSTEMS FOR ORAL SOLID FORMULATIONS-MR MATRIX SYSTEMS RESERVIOR SYSTEMS OSMOTIC
3、AL PUMP SYSTEMS COMBO-SYSTEMS,缓控释给药的技术平台和给药系统 CONCEPT-2 BUILD UP A SYSTEM,Product Development Roadmap 仿制药的研发过程, Quality Acceptably low risk of failing to achieve the desired clinical attributes Pharmaceutical Quality = f drug substance, excipients, manufacturing QbD Product and process performance c
4、haracteristics scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches,What is QbD (Quality by Design )? QbD在制剂开发中怎么体现?,What is QbD? QbD在制剂开发中怎么体现?,Pharmaceutical Quality by Design (QbD) QbD means designing and developing formulations and
5、manufacturing processes to ensure predefined product quality Understanding and controlling formulation and manufacturing process variables affecting the quality of a drug product,Essential elements of QbD Definition of the quality target product profile High level quality aspects of the product: pur
6、ity, drug release (dissolution/disintegration time), pharmacokinetic profile, etc. Critical quality attributes (CQAs) for drug product Characteristics of DP which have impact on desired profile Conscious attempt to study and control Critical Process Parameters (CPPs) Identification of material prope
7、rties and process parameters which have effect on product CQAs Design Space: The multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality Identification of a control strategy for critical process parameters,Wha
8、t is QbD? QbD在制剂开发中怎么体现?,Raw Materials,Equipment,Environment,Operators,Variable Inputs,x,“Locked” Process,=,Variable Quality,How Did We Work in the Past,What is QbD? QbD在制剂开发中怎么体现?,Raw Materials,Equipment,Environment,Operators,Understood Variable Inputs,x,Understood and Controlled Process,=,Predefin
9、ed Quality,Flexible Process Design Space,How Can We Work in the Future,What is QbD? QbD在制剂开发中怎么体现?,What is QbD? QbD在制剂开发中怎么体现?,Raw Materials,Wet Granulation,Fluid Bed Drying,Blending,Compression,Product,Drug Substance,Excipients,Source Assay Impurities LOD PS ,What is QbD? QbD在制剂开发中怎么体现?,Water Binde
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 报批 美国 FDA 制药 研发 相关 问题 探讨
链接地址:https://www.31doc.com/p-3112429.html