Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products (Presentation)

Outline

• Excipient safety review in generic drug applications

• Bridging justifications for excipients in generic drugs – What is their utility?

   – What are important factors to consider?

• Case Studies

  – Excipient grade, dose, duration, route of administration, patient population

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Bridging Justifications: Supporting the Safety of Excipients inGeneric Drug Products
Robert T. Dorsam, Ph.D.
Office of Generic Drugs (OGD) Division of Clinical Review (DCR) Pharmacology/Toxicology Team Leader
FDA USP Bridging Justification Dorsam.pd
Adobe Acrobat Document 495.5 KB

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