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.
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References
Australian Pesticides and Veterinary Medicines Authority (APVMA): Bioequivalence guidelines for veterinary chemical products—guideline 13. http://www.apvma.gov.au/publications/guidelines/gl13_bioequivalence.php (2010). Accessed March 2011.
Health Canada's Veterinary Drugs Directorate (VDD): Guidance for industry—preparation of veterinary abbreviated new drug submissions—generic drugs. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/vet/legislation/guide-ld/vdd-guide-ands-padn-eng.pdf (2010). Accessed May 2010.
Committee for Medicinal Products for Veterinary Use/European Medicines Agency (CVMP/EMA): Guideline for the Conduct of Bioequivalence Studies for Veterinary Medicinal Products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105372.pdf (2011). Accessed November 2011.
Japan's Ministry of Agriculture, Forestry and Fisheries/National Veterinary Assay Laboratory (MAFF/NVAL): Notice 12 NVAL A No. 418, section 5, appendix 8, guideline 11-1. (in Japanese) http://www.maff.go.jp/nval/hourei_tuuti/pdf/12-d-418-b08-23-d-3367.pdf (2011).
New Zealand's Ministry of Agriculture and Forestry/Agricultural Chemicals and Veterinary Medicines (MAF/ACVM): ACVM registration standard and guideline for therapeutic equivalence of trade name products. http://www.foodsafety.govt.nz/elibrary/industry/Acvm_Registration_Standard_Guideline_Therapeutic-Chemicals_Medicines.pdf (2000). Accessed June 2011.
United States' Food and Drug Administration/Center for Veterinary Medicine (FDA/CVM): Guidance for industry—bioequivalence guidance #35. FDA/CVM. http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052363.pdf (2006). Accessed May 2010.
Qureshi SA, McGilveray IJ. Assessment of pharmaceutical quality of furosemide tablets from multinational markets. Drug Dev Ind Pharm. 1998;24(11):995–1005.
Acknowledgments
The author would like to acknowledge the invaluable contribution of several regulatory agents for ensuring the accuracy of their country's tables and for their editorial help. As well, this author would also like to thank the following people for their editorial contribution: Drs. Erik De Ridder, Robert P. Hunter and Bill Zollers.
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Lainesse, C. International Veterinary Bioequivalence Guideline Similarities and Differences Between Australia, Canada, Europe, Japan, New Zealand and the United States. AAPS J 14, 792–798 (2012). https://doi.org/10.1208/s12248-012-9393-y
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DOI: https://doi.org/10.1208/s12248-012-9393-y