報(bào)批美國fda仿制藥研發(fā)與相關(guān)問題探討-final-展示頁
2024-12-17 09:37本頁面
【正文】 TEAM INFORMATION FORMULATION PRODUCT REGULATORY ANALYTICAL BIOPHARMACEUTICAL PROJECT LEGEL ? DRUG DELIVERY SYSTEMS FOR ORAL SOLID FORMULATIONSMR – MATRIX SYSTEMS – RESERVIOR SYSTEMS – OSMOTICAL PUMP SYSTEMS – COMBOSYSTEMS 緩控釋給藥的技術(shù)平臺(tái)和給藥系統(tǒng) CONCEPT2 BUILD UP A SYSTEM Product Development Roadmap 仿制藥的 研發(fā)過程 ? 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在制劑開發(fā)中怎么體現(xiàn)？ What is QbD? QbD在制劑開發(fā)中怎么體現(xiàn)？ ? 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), pharmacokiic 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 bination 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 What is QbD? QbD在制劑開發(fā)中怎么
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