Managing Bioequivalence Risks for Nitrosamine Impacted Drug Products Containing BCS IV Drug Substances

Author/sZhang, Qi

Date:11/07/2024

Meeting Name:FDA and the Center for Research on Complex Generics (CRCG) Workshop on Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products

State:MD

City:Rockville