20xx年醫(yī)學專題—開發(fā)報批美國fda的仿制藥與相關問題探討-文庫吧資料
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【正文】 on optimized? ? Manufacturing Process – How are the manufacturing steps (unit operations) related to the drug product quality? – How were the critical process parameters identified, monitored, and/or controlled? ? Pharmaceutical Development ? Manufacture ? Container Closure System,第二十二頁，共四十一頁。)開發(fā)中怎么體現(xiàn)？,Feed Frame Tooling Punch Penetration Depth Compression Force Press Speed Feeder Speed … …,第二十頁，共四十一頁。,What is QbD? QbD在制劑(zh236。)開發(fā)中怎么體現(xiàn)？,Air Flow Temp RH Shock Cycle P.S.,第十八頁，共四十一頁。,What is QbD? QbD在制劑(zh236。j236。,Drug Substance,Excipients,Source Assay Impurities … … LOD PS … …,What is QbD? QbD在制劑開發(fā)(kāifā)中怎么體現(xiàn)？,第十六頁，共四十一頁。j236。,Raw Materials,Equipment,Environment,Operators,Understood Variable Inputs,x,Understood and Controlled Process,=,Predefined Quality,Flexible Process Design Space,How Can We Work in the Future,What is QbD? QbD在制劑開發(fā)(kāifā)中怎么體現(xiàn)？,第十四頁，共四十一頁。,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 wh
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