title: Current challenges facing the determination of product bioequivalence in veterinary medicine.
abstract: Despite the pharmacological and statistical advances that have occurred since the early days of bioequivalence assessments, there remain many unresolved issues associated with the bioequivalence evaluation of human and veterinary pharmaceuticals. While many of these issues are common to both human and veterinary medicine, there are also challenges specific to veterinary drug products. Examples of complex problems that remain to be resolved include the assessment of drugs associated with complex kinetics (e.g., sustained release formulations that produce multiple peaks), the evaluation of intramammary formulations, uncertainty associated with conditions under which specific enantiomers of metabolites need to be factored into the bioequivalence evaluation, the study design for products and active pharmaceutical ingredients that exhibit highly variable kinetics, equivalence of biomass products, methods for evaluating topical formulations or formulations with very long duration of release, the evaluation of products where destructive sampling is necessary (e.g., aquaculture products), and the evaluation of bioequivalence for Type A medicated articles. This manuscript highlights many of the unresolved challenges currently impacting the evaluation of product bioequivalence in veterinary medicine, and provides a summary of the associated scientific complexities with each of these issues.
authors.affiliation: US Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, Rockville, MD 20855, USA. marilyn.martinez@fda.hhs.gov
authors.forename: M N
authors.initials: MN
authors.lastname: Martinez
authors.forename: R P
authors.initials: RP
authors.lastname: Hunter
mesh_terms: D000818:Animals; D004304:Dosage Forms; D004333:Drug Administration Routes; D007880:Legislation, Drug; D013810:Therapeutic Equivalency; D019155:Veterinary Drugs / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*
chemical_list: D004304:Dosage Forms; D019155:Veterinary Drugs