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)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.