Distilling a Complex Problem into Quantitative Tools and Approaches to Address N-nitrosamine Formation Risk in Drug Products

Author/sMoser, Justin

Date:06/15/2023

Meeting Name:FDA and the Center for Research on Complex Generics (CRCG) Workshop on Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generics

State:MD

City:Rockville