20xx年醫(yī)學(xué)專(zhuān)題—報(bào)批美國(guó)fda仿制藥研發(fā)與相關(guān)問(wèn)題探討-final(編輯修改稿)
2024-11-10 01:05 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 四十一頁(yè)。,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(kāi)發(fā)(kāifā)中怎么體現(xiàn)？,第十四頁(yè)，共四十一頁(yè)。,What is QbD? QbD在制劑開(kāi)發(fā)中怎么(zěn me)體現(xiàn)？,,,Raw Materials,Wet Granulation,Fluid Bed Drying,Blending,Compression,Product,第十五頁(yè)，共四十一頁(yè)。,Drug Substance,Excipients,Source Assay Impurities … … LOD PS … …,What is QbD? QbD在制劑開(kāi)發(fā)(kāifā)中怎么體現(xiàn)？,第十六頁(yè)，共四十一頁(yè)。,Water Binder Temp Spray Rate Speed Time P.S,What is QbD? QbD在制劑開(kāi)發(fā)(kāifā)中怎么體現(xiàn)？,第十七頁(yè)，共四十一頁(yè)。,What is QbD? QbD在制劑(zh236。j236。)開(kāi)發(fā)中怎么體現(xiàn)？,Air Flow Temp RH Shock Cycle P.S.,第十八頁(yè)，共四十一頁(yè)。,What is QbD? QbD在制劑開(kāi)發(fā)中怎么(zěn me)體現(xiàn)？,Fill Volume Rotation Speed End Point (Time) Blend Uniformity Densities Angle of Repose,第十九頁(yè)，共四十一頁(yè)。,What is QbD? QbD在制劑開(kāi)發(fā)中怎么(zěn me)體現(xiàn)？,Feed Frame Tooling Punch Penetration Depth Compression Force Press Speed Feeder Speed … …,第二十頁(yè)，共四十一頁(yè)。,Quality Assessment under QbR,Questionbased Review (QbR) is a general framework for a science and riskbased assessment of product quality QbR contains the important scientific and regulatory review questions to Comprehensively assess critical formulation and manufacturing process variables Set regulatory specifications relevant to quality Determine the level of risk associated with the manufacture a
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