title: International veterinary bioequivalence guideline similarities and differences between Australia, Canada, Europe, Japan, New Zealand and the United States.
abstract: Considering the diversity in physiology between species and the numerous dosage forms that exist in veterinary drug products, there are numerous complex issues that arise from the development and regulation of veterinary drugs for food-producing and companion animals. Generic drugs are no exception. The main objective of this article is to illustrate the current important similarities and differences between international veterinary bioequivalence guidelines. It is concluded that since important differences are found, these may lead to barriers in international data exchange and scientific confusion, hence fostering the need for a harmonization effort in developing consistent guidelines based on sound pharmacological and statistical principles for the approval of veterinary generic drugs around the world.
authors.affiliation: IntegRxal Consulting Strategies, Site 515, Box 17, RR5, Saskatoon, Saskatchewan, Canada, S7K 3J8. ch.lainesse@gmail.com
authors.forename: Chantal
authors.initials: C
authors.lastname: Lainesse
mesh_terms: D000818:Animals; D015195:Drug Design; D016568:Drugs, Generic / Q000493:pharmacokinetics*; D017408:Guidelines as Topic; D007391:International Cooperation; D038622:Internationality; D013045:Species Specificity; D013810:Therapeutic Equivalency; D019155:Veterinary Drugs / Q000008:administration & dosage / Q000493:pharmacokinetics*
chemical_list: D016568:Drugs, Generic; D019155:Veterinary Drugs