開发报批美国FDA的仿制药与相关问题探讨何平.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;内容提要;开发仿制药的重要性 ;开发仿制药的挑战性 ;仿制药竞争的方式HOW TO COMPETE ;申报(仿制)新药的分类;仿制药研发团队CONCEPT-1 BUILD UP A TEAM;DRUG DELIVERY SYSTEMS FOR ORAL SOLID FORMULATIONS-MR MATRIX SYSTEMS RESERVIOR SYSTEMS OSMOTICAL PUMP SYSTEMS COMBO-SYSTEMS;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? QbD在制剂开发中怎么体现？;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 parameters that have been demonstrated to provide assurance of quality ?? Identification of a control strategy for critical process parameters;Raw Materials;Raw Materials;What is QbD? QbD在制剂开发中怎么体现？; Drug Substance;Water Binder Temp Spray Rate Speed Time P.S ;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？;What is QbD? QbD在制剂开发中怎么体现？;Quality Assessment under QbR;Examples of QbD questions under QbR ? Control of Drug Substance – What is the drug substance specification? Does it include all the critical drug substance attributes that affect the manufacturing and quality of the drug product? (2 pages) ? Drug Product – What attributes should the drug product possess? (1.5 pages) – How were the excipients and their grades selected? – H