Dissolution specification for generic oral immediate release products - Scientific guideline

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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

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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

English (EN) (156.9 KB - PDF)

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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

English (EN) (751.96 KB - PDF)

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

Draft: consultation closed Consultation dates: to 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.

English (EN) (146.32 KB - PDF)

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