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Updated: May 24, 2026

Preparation of Herbal Medicine: Er-Xian Decoction and Er-Xian-containing Serum for In Vivo and In Vitro Experiments
Published on: May 31, 2017
Considerations for extrapolating in vivo bioequivalence data across species and routes
S Modric1, E Bermingham, M Heit
1Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD 20886, USA. sanja.modric@fda.hhs.gov
Abstract:
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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