Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities

P. Bercu, Joel; C. Berlam, Susan; C. Berridge, John; Cherney, Barry; S. Cowley, Deborah; W. Laughton, H.; K. McLoughlin, D.; McMahon, Megan; Moore, Christine; Sekhar Krishna Murti, Chandra; O'Neill, Julia; L. Parsons, Rodney; Peng, Dahua; W. Quan, R.; Subashi, Ann; Teasdale, Andrew; Tyler, Stephen; Watson, Timothy

doi:10.1007/s12247-018-9366-5

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Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities

Shared by NobleBlocks on Dec 13, 2018 • 12:00 AM UTC

Authors:

Joel P. Bercu

Susan C. Berlam

John C. Berridge

Abstract

In this paper, we remind readers of several ICH guideline documents such as ICH Q3A, Q3B, Q3C, Q3D, Q6A, Q6B, M7, and ICH S9 which are related to the drug substance and drug product impurity limit setting. In particular, ICH Q6A clearly states that “specifications should focus on those characteristi...

Subject

Relevance (law)

Guideline

Product (mathematics)

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