title: Challenges obtaining a biowaiver for topical veterinary dosage forms.
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.
authors.affiliation: College of Veterinary Medicine, North Carolina State University, Raleigh, NC, USA. ronald_baynes@ncsu.edu
authors.forename: R
authors.initials: R
authors.lastname: Baynes
authors.forename: J
authors.initials: J
authors.lastname: Riviere
authors.forename: T
authors.initials: T
authors.lastname: Franz
authors.forename: N
authors.initials: N
authors.lastname: Monteiro-Riviere
authors.forename: P
authors.initials: P
authors.lastname: Lehman
authors.forename: M
authors.initials: M
authors.lastname: Peyrou
authors.forename: P-L
authors.initials: PL
authors.lastname: Toutain
mesh_terms: D000287:Administration, Topical; D000818:Animals; D004304:Dosage Forms; D004333:Drug Administration Routes; D007880:Legislation, Drug; D013045:Species Specificity; D013810:Therapeutic Equivalency; D019155:Veterinary Drugs / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*
chemical_list: D004304:Dosage Forms; D019155:Veterinary Drugs