Development pharmaceutics - Scientific guideline

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.

Keywords: Development pharmaceutics, formulation, quality, product, dosage form

Current effective version

Note for guidance on development pharmaceutics

Adopted Reference Number: CPMP/QWP/155/96 Legal effective date: 01/07/1998