Development pharmaceutics

Current effective version

PDF iconAdopted guideline

Reference number CPMP/QWP/155/96
Published 28/01/1998
Effective from 01/07/1998
Keywords Development pharmaceutics, formulation, quality, product, dosage form
Description This 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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