Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals.
Horne S, Vera MD, Nagavelli LR, Sayeed VA, Heckman L, Johnson D, Berger D, Yip YY, Krahn CL, Sizukusa LO, Rocha NFM, Bream RN, Ludwig J, Keire DA, Condran G.
Horne S, et al. Among authors: yip yy.
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J Pharm Sci. 2023.
PMID: 36599405