Dissolution specification for generic oral immediate release products - Scientific guideline

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 version

Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action - First version

Reference Number: EMA/CHMP/CVMP/QWP/336031/2017

Document history - First version (current)

Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action - First version

Reference Number: EMA/CHMP/CVMP/QWP/336031/2017

Overview of comments received on 'Draft reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action' - First version

Reference Number: EMA/CHMP/CVMP/QWP/257305/2017

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.