* * * * * * * * * * * * * * * * * * 案例研究-3CASE STUDY 3 - ER CAPSULES Brand Product Micro-Tablets in Capsules 95% of API existed in Finished Product System and Process Patented UNIQUE SYSTEM-CREATIVE DESIGN Compressed Granules in Capsules Requirement Same Dissolution Behavior Uniform Yield Acceptable  SYSTEM COMPARISON  PILOT BIO-STUDY PRODUCT P DATA (Log Transformed Data, Fast, n-12) Ratio of Geometric Means x 100 90% CI of Log Transformed Data CV (%) Test A vs Reference AUC 106 90.4; 123 22.0 Cmax 104 80.1; 134 36.4 Test B vs Reference AUC 133 114; 155 22.0 Cmax 129 100; 167 36.4 PILOT BIO-STUDY PRODUCT P DATA (Log Transformed Data, FED, n-11) Ratio of Geometric Means x 100 90% CI of Log Transformed Data CV (%) Test A  vs Reference AUC 96.1 75.4; 123 32.7 Cmax 109 83.5; 141 35.3 Test B  vs Reference AUC 92.4 72.5; 118 32.7 Cmax 109 83.7; 141 35.3 PIVOTAL BIO-STUDY PRODUCT P DATA (Log Transformed Data) Ratio of Geometric Means x 100 90% CI of Log Transformed Data CV (%) FAST AUC 102 93; 111 33,9 Cmax 105 94.5; 116 38.8 FED AUC 98.8 91.6; 107 26.4 Cmax 99.6 89.2; 111 38.4 案例研究-4 CASE STUDY 4 - ER CAPSULES API is Water Soluble.  Prototype formulation was proposed based on in vitro dissolution (OGD method). PILOT BIO-STUDY PRODUCT DATA (Log Transformed Data) AUC0-t AUC0-inf Cmax T-1 Ratio 111.21% 112.48% 140% 90% Geometric C.I. 104.40% to 118.47% 105.78% to 119.60% 133.7% to 147.0% T-2 Ratio 117.5% 117.2% 135.9% 90% Geometric C.I. 113.2% to 122.2% 112.4% to 122.1% 129.5% to 142.4% Further Investigation 谢谢! 139-1866-7400 paxhp@yahoo.com * * 2011年至2015年间将有770亿美元销售的专利药到期  * * * MR Product-Not every company could produce the products * MR Product-Not every company could produce the products 开发仿制药的核心是时间和效率,怎样在最短的时间里把产品开发出来. * * * * * * * * * * * * * * * * 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 INFORMATION FORMULATION PRODUCT REGULATORY ANALYTICAL BIO-PHARMACEUTICAL PROJECT LEGEL 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 proce
报批美国FDA仿制药研发与相关问题探讨-何平.ppt