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Search results with tag "Impurities in new drug products"
Q 3 B (R2) Impurities in New Drug Products
www.ema.europa.euof impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or member state. 1.2 Background This guideline is complementary to the ICH Q3A(R) guideline “Impurities in New Drug Substances”, which should be consulted for basic principles.
Q 3 B (R2) Impurities in New Drug Products
www.ema.europa.eu© EMEA 2006 3 IMPURITIES IN NEW DRUG PRODUCTS I. INTRODUCTION 1.1 Objective of the guideline This document provides guidance for registration applications on the ...