课件：报批美国FDA仿制药研发与相关问题探讨Final.ppt

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * What is QbD? QbD在制剂开发中怎么体现？ Raw Materials Wet Granulation Fluid Bed Drying Blending Compression Fill Volume Rotation Speed End Point (Time) Blend Uniformity Densities Angle of Repose What is QbD? QbD在制剂开发中怎么体现？ Raw Materials Wet Granulation Fluid Bed Drying Blending Compression Feed Frame Tooling Punch Penetration Depth Compression Force Press Speed Feeder Speed … … THANK YOU SUCCESS * * 可编辑 Quality Assessment under QbR Question-based Review (QbR) is a general framework for a science and risk-based assessment of product qual