Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes

David J. Ponting, Robert Thomas, Joerg Schlingemann(Merck KGaA, Darmstadt (Germany)), Andrew Teasdale(AstraZeneca (United Kingdom)), James Harvey(GlaxoSmithKline (United Kingdom)), Raphael Nudelman(Applied Materials (Israel)), Stéphanie Simon(Merck KGaA, Darmstadt (Germany)), Andreas Czich(Sanofi (Germany)), Susanne Glowienke(Novartis (Switzerland)), Susan P. Felter(Procter & Gamble (United States)), G. Smith(AstraZeneca (United Kingdom))
Regulatory Toxicology and Pharmacology
December 9, 2024
Cited by 13


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