5_Dissolution_-_Validation_China_July_2004精选.ppt

Dissolution Method Validation Outline purpose and strategy critical validation parameters considerations for dissolution considerations for sample analysis examples Purpose of dissolution test detect formulation and process changes (quality control) compare drug products of different formulation and process (product development) dissolution rate (in-vitro) should reflect release/absorption rate in human (in-vivo) Strategies of Dissolution Method Validation (1) Strategies of Dissolution Method Validation (2) Strategies of Dissolution Method Validation (3) Validation Requirements Critical Param