[Elsevier] Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products

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journal:Regulatory Toxicology and Pharmacology

Authors:Susan P. Felter; Joel P. Bercu; Robert A. Jolly; Timothy J. McGovern; Yi Yang; Alejandra Trejo-Martin; Roland Froetschl; Bodo Haas; Kelly Brant; Alisa Vespa; David J. Ponting; Anthony Lynch; Ashley M. Mudd; Angela White; Andreas Zeller; Raechel Puglisi

Published date:2026-9-

DOI:10.1016/j.yrtph.2026.106245

PDF link:https://www.sciencedirect.com/sc ... 273230026002187/pdf

Article link:https://doi.org/10.1016/j.yrtph.2026.106245

Article Source:Elsevier BV


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