Development pharmaceutics

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Current effective version

Adopted guideline

Reference numberCPMP/QWP/155/96
Published28/01/1998
Effective from01/07/1998
KeywordsDevelopment pharmaceutics, formulation, quality, product, dosage form
DescriptionThis document provides guidance on the data from pharmaceutical development studies required for marketing authorisation. It aims to facilitate the application of Part II, sections A.4 of the Annex to Directive 75/318/EEC, as amended. Read together with the annex on decision trees for selection of sterilisation methods.


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