N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da
Joel P. Bercu(Gilead Sciences (United States)), Mike W Urquhart(Age UK), James Harvey(GlaxoSmithKline (United Kingdom)), Raphael Nudelman(Applied Materials (Israel)), Michelle Kenyon(Pfizer (United States)), Robert A. Jolly(Eli Lilly (United States)), Krista L. Dobo(Pfizer (United States)), Olivier Dirat(Pfizer (United Kingdom)), Alejandra Trejo‐Martin(Gilead Sciences (United States)), G. Smith(AstraZeneca (United Kingdom))
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