Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline

This document provides guidance on the data from pharmaceutical development studies required for marketing authorisation. It focuses on formulation and pre-formulation studies during the development of a suitable dosage form for active substances produced by biological or biotechnological means.

Keywords: Pharmaceutical development, biological, biotechnological, characterisation, manufacturing, overages, compatibility, stability

Current effective version

Development pharmaceutics for biotechnological and biological products (CPMP/BWP/328/99) Annex to note for guidance on development pharmaceutics (CPMP/QWP/155/96)

Adopted Reference Number: CPMP/BWP/328/99 Legal effective date: 01/04/2000