Dissolution specification for generic oral immediate release products

This document discusses the suitability of the dissolution method and the specifications for in vitro dissolution of orally administered generic drug products with immediate release characteristics.

Keywords: Dissolution specification, generic, oral immediate release product

Current effective version

Draft reflection paper on the dissolution specification for generic oral immediate release products - First version

Draft: consultation closed Consultation dates: 13/05/2016 to 13/08/2016 Reference Number: EMA/CHMP/CVMP/QWP/37330/2016 Summary:

This document discusses the suitability of the dissolution method and the specifications for in vitro dissolution of orally administered generic drug products with immediate release characteristics.