Non-clinical development of fixed combinations of medicinal products

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Current effective version

Adopted guideline

Reference numberCHMP/SWP/258498/05
Published24/01/2008
Effective from01/08/2008
KeywordsFixed combination, new active substance, safety pharmacology, toxicity studies
DescriptionThis document provides guidance on the non-clinical strategies to be considered when developing a fixed combination based on the different data available. It may also apply to the development of a combination therapy not involving a fixed combination formulation.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/08/2008–present


Published: 13/10/2005


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