Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members

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DOI:10.1021/acs.oprd.4c00033
作者：Steven Tymonko*,?Brenda J. Burke,?Jean-Philippe Crochard,?Olivier Dirat,?Kenneth J. Fraunhoffer,?Cristian Harrison,?Timothy Kramer,?Heewon Lee,?Vlad Liberman,?Kanwar P. S. Sidhu,?Randi Smith,?Neil A.
文献类型：期刊论文
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American Chemical Society (ACS)

Abstract：The designation and justification of active pharmaceutical ingredient starting materials (API SMs) is a crucial aspect of the drug substance (DS) commercialization process. Over the past dec

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