Fixed-dose procedure
The fixed-dose procedure (FDP), proposed in 1984 by the British Toxicology Society, is a method to assess a substance's acute oral toxicity.[1][2]
In comparison to the older LD50 test developed in 1927, this procedure produces similar results while using fewer animals and causing less pain and suffering.[3] As a result, in 1992 this test was proposed as an alternative to the LD50 test by the Organisation for Economic Co-operation and Development under OECD Test Guideline 420.[4] However, the U.S. Food and Drug Administration has begun to approve non-animal alternatives in response to research cruelty concerns and the lack of validity/sensitivity of animal tests as they relate to humans.[5][6]
See also
References
- Stallard, N.; Whitehead, A. (2 July 2016). "Reducing animal numbers in the fixed-dose procedure". Human & Experimental Toxicology. 14 (4): 315–323. doi:10.1177/096032719501400401. PMID 7598991.
- Walum, E (April 1998). "Acute oral toxicity". Environmental Health Perspectives. 106 (Suppl 2): 497–503. doi:10.1289/ehp.98106497. JSTOR 3433801. PMC 1533392. PMID 9599698.
- van den Heuvel, M.J.; Clark, D.G.; Fielder, R.J.; Koundakjian, P.P.; Oliver, G.J.A.; Pelling, D.; Tomlinson, N.J.; Walker, A.P. (January 1990). "The international validation of a fixed-dose procedure as an alternative to the classical LD50 test". Food and Chemical Toxicology. 28 (7): 469–482. doi:10.1016/0278-6915(90)90117-6. PMID 2210519.
- Stallard, N; Whitehead, A; Ridgway, P (2 July 2016). "Statistical evaluation of the revised fixed-dose procedure". Human & Experimental Toxicology. 21 (4): 183–196. doi:10.1191/0960327102ht239oa. PMID 12099620.
- "Allergan Receives FDA Approval for First-of-Its-Kind, Fully in vitro, Cell-Based Assay for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA)" (Press release). Allergan. June 24, 2011. Retrieved May 19, 2020.
- Gaul, Gilbert M. (12 April 2008). "In U.S., Few Alternatives To Testing On Animals". The Washington Post.
Further reading
- Whitehead, A.; Curnow, R.N. (April 1992). "Statistical evaluation of the fixed-dose procedure". Food and Chemical Toxicology. 30 (4): 313–324. doi:10.1016/0278-6915(92)90009-a. PMID 1628867.
- Lipnick, R.L.; Cotruvo, J.A.; Hill, R.N.; Bruce, R.D.; Stitzel, K.A.; Walker, A.P.; Chu, I.; Goddard, M.; Segal, L.; Springer, J.A.; Myers, R.C. (March 1995). "Comparison of the up-and-down, conventional LD50, and fixed-dose acute toxicity procedures". Food and Chemical Toxicology. 33 (3): 223–231. doi:10.1016/0278-6915(94)00136-c. PMID 7896233.
- Yam, J.; Reer, P.J.; Bruce, R.D. (January 1991). "Comparison of the up-and-down method and the fixed-dose procedure for acute oral toxicity testing". Food and Chemical Toxicology. 29 (4): 259–263. doi:10.1016/0278-6915(91)90023-Z. PMID 2040488.
- Stallard, Nigel; Whitehead, Anne (9 April 2019). "A Statistical Evaluation of the Fixed Dose Procedure". Alternatives to Laboratory Animals. 32 (2_suppl): 13–21. doi:10.1177/026119290403202s05. PMID 15601221.
- Stallard, N.; Whitehead, A. (2 July 2016). "The fixed-dose procedure and the acute-toxic-class method: a mathematical comparison". Human & Experimental Toxicology. 14 (12): 974–990. doi:10.1177/096032719501401206. PMID 8962748.
- Stallard, Nigel; Whitehead, Anne; Indans, Ian (2 July 2016). "Statistical evaluation of an acute dermal toxicity test using the dermal fixed dose procedure". Human & Experimental Toxicology. 23 (8): 405–412. doi:10.1191/0960327104ht465oa. PMID 15346722.
- Ellard, GA (November 1999). "The evaluation of rifampicin bioavailabilities of fixed-dose combinations of anti-tuberculosis drugs: procedures for ensuring laboratory proficiency". The International Journal of Tuberculosis and Lung Disease. 3 (11 Suppl 3): S322-4, discussion S351-2. PMID 10593711.
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