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Lecture 12: Biowaivers and Their Role in Product Lifecycle

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Learning Objectives:
  • Review biowaivers and describe their role throughout the product life-cycle.
    • Benefits and Risks
    • Exceptions from Biowaiver
    • Types and Requirements (FDA, EMA, Health Canada, WHO, Japan):
      • BCS based biowaiver;
      • Biowaiver for line of strengths;
      • Biowaiver for post-approval changes