Potency and safety analysis of hemp-derived delta-9 products: The hemp vs. cannabis demarcation problem

The fixed-dose procedure (FDP), proposed in 1992 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


  1. ^ 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. S2CID 37663587.
  2. ^ 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.
  3. ^ 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.
  4. ^ 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. S2CID 45430481.
  5. ^ "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.
  6. ^ Gaul, Gilbert M. (12 April 2008). "In U.S., Few Alternatives To Testing On Animals". The Washington Post.

Further reading