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

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/BWP/328/99
Published21/10/1999
Effective from01/04/2000
KeywordsPharmaceutical development, biological, biotechnological, characterisation, manufacturing, overages, compatibility, stability
DescriptionThis document provides guidance on the data from pharmaceutical development studies required for marketing authorisation. It focuses on formulation and pre-formulation studies during the developmnet of a suitable dosage form for active substances produced by biological or biotechnological means.


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