ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

Author(s): Keith McDonald, MSc, MRPharmS, Kowid Ho, PhD

Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical principles relating to the development and description of the drug substance manufacturing process to be included within the Common Technical Document (CTD) and submitted to […]

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