报批美国FDA仿制药研发与相关问题探讨Final.pptVIP

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 Materials 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 OSMOTICAL 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 characteristics 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 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: purity, 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 properties and process parameters which have effect on product CQAs ?? Design Space: The multidimensional combination and interaction of input variables and process pa