From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 62
Product Approval
Research studies in animal models are necessary to determine whether a new drug has
a pharmacological property that might mediate a human disease process, with a toxic-
ity profile that will not cause adverse experiences in humans at pharmacological doses.23
Rats are the primary animals used for that purpose. FDA requires a six-month rodent
toxicology or combined rat chronic toxicity/carcinogencity (two-year) study, and a repro-
ductive/development toxicity study in rats or other appropriate rodent species in the
nonclinical drug development stage of a New Drug Application. Rats are used in phar-
macology, toxicology and biocompatibility studies and in multiple fields of research. The
National Association for Biomedical Research estimates that approximately 25 million rats
and mice are used annually, just in US laboratories.24
References
1. Editorial: “The plague of rats.” Journal of the American Medical Association, 1907 49:148-9.
2. Sullivan J. Rats. Bloomsbury Publishing, New York, 2004.
3. Ibid.
4. Angier N. “Smart, curious, ticklish. Rats?” The New York Times, 24 July 2007.
5. http://www.ratbehavior.org/history.htm (Accessed 6 September 2007).
6. McCormick M. “Rats, communications and plague.” J Interdisciplinary History 2003 xxxiv (1): 1-25.
7. Op cit 4.
8. Marrin A. Oh, Rats! Dutton, New York, 2006.
9. Rosen W. Justinian’s Flea, Viking Books, New York, 2007.
10. Op cit 5.
11. Op cit 8.
12. Op cit 9.
13. Op cit 2.
14. Ibid.
15. Clause BT. “The Wistar rat as a right choice: Establishing mammalian standards and the ideal of a standard-
ized animal.” J. Hist Biol 1993: 26(2):329-49.
16. Ibid.
17. Foster HL. “The history of commercial production of laboratory rodents.” Laboratory Animal Sci 1980
30(4):793-8
18. Op cit 15.
19. Op cit 4.
20. Watamabe TK et al. “A radiation hybrid map of the rat genome containing 5,255 markers.” Nature Genetics.
1999 22:27-36.
21. http://sciencedaily.com/releases (accessed 29 September 07).
22. Op cit 4.
23. Lakings DB. Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology in the New Drug
Approval Process 4th Ed. R. Guarino editor, Marcel Dekker Inc., New York, 2004.
24. Trull FL and Rich BA. “More regulation of rodents.” Science. 1999 284:1463.
Published in Regulatory Focus, June 2008. Copyright © 2008 Regulatory Affairs Professionals Society.
Product Approval
Research studies in animal models are necessary to determine whether a new drug has
a pharmacological property that might mediate a human disease process, with a toxic-
ity profile that will not cause adverse experiences in humans at pharmacological doses.23
Rats are the primary animals used for that purpose. FDA requires a six-month rodent
toxicology or combined rat chronic toxicity/carcinogencity (two-year) study, and a repro-
ductive/development toxicity study in rats or other appropriate rodent species in the
nonclinical drug development stage of a New Drug Application. Rats are used in phar-
macology, toxicology and biocompatibility studies and in multiple fields of research. The
National Association for Biomedical Research estimates that approximately 25 million rats
and mice are used annually, just in US laboratories.24
References
1. Editorial: “The plague of rats.” Journal of the American Medical Association, 1907 49:148-9.
2. Sullivan J. Rats. Bloomsbury Publishing, New York, 2004.
3. Ibid.
4. Angier N. “Smart, curious, ticklish. Rats?” The New York Times, 24 July 2007.
5. http://www.ratbehavior.org/history.htm (Accessed 6 September 2007).
6. McCormick M. “Rats, communications and plague.” J Interdisciplinary History 2003 xxxiv (1): 1-25.
7. Op cit 4.
8. Marrin A. Oh, Rats! Dutton, New York, 2006.
9. Rosen W. Justinian’s Flea, Viking Books, New York, 2007.
10. Op cit 5.
11. Op cit 8.
12. Op cit 9.
13. Op cit 2.
14. Ibid.
15. Clause BT. “The Wistar rat as a right choice: Establishing mammalian standards and the ideal of a standard-
ized animal.” J. Hist Biol 1993: 26(2):329-49.
16. Ibid.
17. Foster HL. “The history of commercial production of laboratory rodents.” Laboratory Animal Sci 1980
30(4):793-8
18. Op cit 15.
19. Op cit 4.
20. Watamabe TK et al. “A radiation hybrid map of the rat genome containing 5,255 markers.” Nature Genetics.
1999 22:27-36.
21. http://sciencedaily.com/releases (accessed 29 September 07).
22. Op cit 4.
23. Lakings DB. Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology in the New Drug
Approval Process 4th Ed. R. Guarino editor, Marcel Dekker Inc., New York, 2004.
24. Trull FL and Rich BA. “More regulation of rodents.” Science. 1999 284:1463.
Published in Regulatory Focus, June 2008. Copyright © 2008 Regulatory Affairs Professionals Society.