The purpose of this workshop is to review the current research and recommendations on methods for confirmatory testing of NDSRI formation, safety testing methods for NDSRIs and recommended acceptable intake limits for NDSRIs based on predicted carcinogenic potency and compound-specific data or read-across analysis. The workshop will also discuss strategies to mitigate the risk of NDSRIs formation. Another key focus of the workshop is to provide an update on FDA policy and guidance in assessing formulation stability, and recommendations for bioequivalence approaches when drug developers are considering reformulation.
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products
Date and Time:
November 6
,
8:30 am
–
5:30 pm
,
November 7
,
8:30 am
–
5:30 pm
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)
In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.