USP Excipients Workshop: Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products (On-Demand)

Curriculum

Course Description:

  • A bridging justification is an approach for safety assessments in which toxicology data for one or more compounds are applied to a different compound.
  • Important elements of a bridging justification include the similarity and difference between excipients, existing nonclinical and clinical data, data gaps and the proposed context of use.
  • The U.S. Office of Generic Drugs reviews bridging justifications within ANDAs to ensure excipient safety. Each case is unique, but similar principles apply.

Featuring Robert Dorsam, Ph.D., U.S. FDAAccess Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.

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