Articles with "approval change" as a keyword



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Post-approval Change Submission: ICH Q12 Impact Analysis on India and Japan

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Published in 2020 at "Indian Journal of Pharmaceutical Sciences"

DOI: 10.36468/pharmaceutical-sciences.617

Abstract: The present research provides a discussion on post approval change management of pharmaceuticals, biologics and drug device combinations, which is an important part of life cycle management. The present study focuses on understanding the existing… read more here.

Keywords: india japan; post approval; approval change; ich q12 ... See more keywords