Nitrosamine Drug Impurities and Nitrosamine Drug Substance Related Impurities: Optimizing Mutagenicity Testing

Author/sHeflich, Robert

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