Considerations for extrapolating in vivo bioequivalence data across species and routes

Authors


Sanja Modric, Food and Drug Administration, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20886, USA. E-mail:sanja.modric@fda.hhs.gov

Abstract

Modric, S., Bermingham, E., Heit, M., Lainesse, C., Thompson, C. Considerations for extrapolating in vivo bioequivalence data across species and routes. J. vet. Pharmacol. Therap.35 (Suppl. 1), 45–52.

The purpose of this article is to discuss the numerous species-specific and route-specific factors that can influence the peak and extent of exposure of an active pharmaceutical ingredient as they relate to the demonstration of bioequivalence between veterinary drug products (test and reference formulations). Evaluation of potential circumstances when species-to-species or route-to-route extrapolations of bioequivalence data could be considered is provided, together with suggestions for alternative statistical analysis. It is concluded that further research is much needed in this area to establish an appropriate scientific basis for across-species and across-route comparisons.

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