Challenges obtaining a biowaiver for topical veterinary dosage forms

Ronald E Baynes (1) , Jim Riviere (1) , Thomas Franz (2) , Nancy A Monteiro-Riviere (1) , Paul Lehman (2) , Mathieu Peyrou (3) , Pierre-Louis Toutain (4)

1 Coll Vet Med
2 Cetero Research Corp
3 Novartis
4 ToxAlim - ToxAlim

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.

Domaines: Sciences du Vivant [q-bio]

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⟩