Abstract
Veterinary drugs are important in maintaining the health and productivity of agricultural animals, and the health of companion animals. Although there are many parallels between the development of animal drugs and human drugs, there are also important differences. This article focuses on some key challenges and opportunities for veterinary drug development in the light of the regulatory framework for animal healthcare.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
Similar content being viewed by others
References
Wood Mackenzie. Animal Health Service (Wood Mackenzie, Edinburgh, 2002).
Evans, T. & Chapple, N. The animal health market. Nature Rev. Drug Discov. 1, 937–938 (2002).
21 CFR 510.3.
Title 21, Chapter 9, Subchapter V, Part A, Section 360b.
Animal Drug Availability Act [online] (cited 1 May 2002) <http://www.fda.gov/cvm/index/adaa/adaa66.pdf> (1996).
CVM Update [online] (cited 1 May 2002) <http://www.fda.gov/cvm/index/updates/adaa.html> (1996).
Animal Medicinal Drug Use Clarification Act [online] (cited 1 May 2002) <http://www.fda.gov/cvm/index/amducca/amducatoc.htm> (1994).
Federal Food, Drug and Cosmetic Act (21U. S. C. 301 et seq.).
Federal Register 61, 57732–57746 (1996).
21 CFR part 530.
Federal Register 62, 27944–27945 (1997).
Minor Use and Minor Species Animal Health Act [online] (cited 1 May 2002) <http://www.fda.gov/cvm/index/mums/minortoc.htm> (2001).
Generic Animal Drug Patent Term Restoration Act. [online] (cited 1 May 2002) <http://www.fda.gov/cvm/index/adaa/adaa66.pdf> (1996).
CVMM-50 [online] (cited 1 May 2002) <http://www.fda.gov/cvm/index/memos/cvmm50.html> (1992).
Martinez, M., Langston, C., Martin, T. & Conner, D. Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective. J. Vet. Pharmacol. Ther. 25, 201–220 (2002).
FDA Veterinarian XVII, 1–2 (Sept/Oct 2002).
Teuber, M. Veterinary use and antibiotic resistance. Curr. Opin. Microbiol. 4, 493–499 (2001).
U.S. Food and Drug Administration. A proposed framework for evaluating and assuring the human safety of the microbial effects of antimicrobial new animal drugs intended for use in food–producing animals. Federal Register Jan 6 (1999).
FDA Guidance 152 'Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern' (2002).
Singer, R. S., Finch, R., Wegener, H. C. & Bywater, R. Antibiotic resistance — the interplay between antibiotic use in animals and human beings. People, animals, and antibiotic resistance forum. Lancet Infect. Dis. 3, 47–51 (2003).
To ban or not to ban? Lancet Infect. Dis. 3, 1 (2003).
Flower, R. J. The development of COX2 inhibitors. Nature Rev. Drug Discov. 2, 179–191 (2003).
Johnston, S. A. & Budsberg, S. C. Nonsteroidal anti-inflammatory drugs and corticosteroids for the management of canine osteoarthritis. Vet. Clin. North. Am. Small Anim. Pract. 27, 841–862 (1997).
Streppa, H. K., Jones, C. J. & Budsberg, S. C. Cyclooxygenase selectivity of nonsteroidal anti-inflammatory drugs in canine blood. Am. J. Vet. Res. 63, 91–94 (2002).
Ricketts, A. P. et al. Evaluation of selective inhibition of canine cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti-inflammatory drugs. Am. J. Vet. Res. 59, 1441–1446 (1998).
Gierse, J. K. et al. Cloning, expression, and selective inhibition of canine cyclooxygenase-1 and cyclooxygenase-2. Vet. Ther. 3, 270–280 (2002).
Martel-Pelletier, J., Lajeunesse, D., Reboul, P. & Pelletier, J. P. Therapeutic role of dual inhibitors of 5-LOX and COX, selective and non-selective non-steroidal anti-inflammatory drugs. Ann. Rheum. Dis. 62, 501–509 (2003).
Author information
Authors and Affiliations
Related links
Related links
DATABASES
LocusLink
FURTHER INFORMATION
Center for Veterinary Medicine
Rights and permissions
About this article
Cite this article
Lathers, C. Challenges and opportunities in animal drug development: a regulatory perspective. Nat Rev Drug Discov 2, 915–919 (2003). https://doi.org/10.1038/nrd1229
Issue Date:
DOI: https://doi.org/10.1038/nrd1229