Challenges obtaining a biowaiver for topical veterinary dosage forms - INRAE - Institut national de recherche pour l’agriculture, l’alimentation et l’environnement Access content directly
Journal Articles Journal of Veterinary Pharmacology and Therapeutics Year : 2012

Challenges obtaining a biowaiver for topical veterinary dosage forms

Ronald E Baynes
  • Function : Correspondent author
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Jim Riviere
  • Function : Author
Paul Lehman
  • Function : Author
Mathieu Peyrou
  • Function : Author
Pierre-Louis Toutain
  • Function : Author

Abstract

Obtaining a biowaiver for topical drugs used in veterinary species faces many of the same challenges associated with human topicals. However, the skin of domestic animals varies anatomically and biochemically and experimental approaches to assess bioequivalence (BE) in veterinary species have challenges that are not often encountered with human skin. This is especially the situation with locally acting drugs. The focus of this paper is to address several of the challenges associated with (i) determining the BE of these locally acting drugs and (ii) critically examine the current technological advances that can act as a surrogate for clinical trials.
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Dates and versions

hal-01191257 , version 1 (01-09-2015)

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Ronald E Baynes, Jim Riviere, Thomas Franz, Nancy A Monteiro-Riviere, Paul Lehman, et al.. Challenges obtaining a biowaiver for topical veterinary dosage forms. Journal of Veterinary Pharmacology and Therapeutics, 2012, 35 (1), pp.103-114. ⟨10.1111/j.1365-2885.2012.01381.x⟩. ⟨hal-01191257⟩
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