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U.S. Department of Health and Human Services

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Article, Chapter, or Book Title:  Considerations for extrapolating in vivo bioequivalence data across species and routes
 
Author(s):  Modric S, Bermingham E, Heit M, Lainesse C, Thompson C
 
Year:  2012
 
Month:  April
 
Journal Abbrev, Book Title, or Conference:  J Vet Pharmacol Therap
 
Journal Full Name:  Journal of Veterinary Pharmacology and Therapeutics
 
Volume:  35
 
Start Page:  45
 
End Page:  52
 
Key Words:  bioequivalence, animal species, generic veterinary drug products
 
Abstract:  The purpose of this article was to discuss the numerous factors that can influence the peak and extent of exposure of drugs between different animal species and routes of administration, as they relate to the demonstration of bioequivalence between generic veterinary drug products. The authors 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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