Pharmaceutical equivalence of biotechnological products (biogenerics)

• In: S5 - Quality Assessment of Biotechnological Products on Wednesday, 30 August 2006, 9:00-12:00
• At: Salvadore (Brazil) (2006)
• 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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