报批美国FDA仿制药研发与相关问题探讨-Final.ppt

* * * * * * * * * * * * * * * * * * 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@ * * 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 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