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Pharmaceutical equivalence of biotechnological products (biogenerics)

  • At: 2006 FIP Congress in Salvadore (Brazil)
  • Type: Presentation
  • By: WILLIAMS, Roger (U.S. Pharmacopeia, Executive, Rockville, MD, United States of America)
  • Abstract:

    For a biotechnological product, equivalence experiments to document either pharmaceutical equivalence or bioequivalence—and hence therapeutic equivalence--rely on a broad spectrum of marketplace surveillance, clinical safety and efficacy, pharmacodynamic, pharmacokinetic, non-clinical (animal), a biologic potency test, and physicochemical

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Last update 4 October 2019

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