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Research Article

Revisit the 21-day cumulative irritation test – statistical considerations

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Pages 29-34 | Received 03 Dec 2015, Accepted 09 Jan 2016, Published online: 24 Feb 2016

References

  • Lanman BM, Elverse EB, Howard CS. The role of human patch testing in a product development program. In: Proceedings, Joint Conference on Cosmetic Sciences. Washington DC: The Toilet Goods Association, Inc.; 1968:135--145
  • Berger RS, Bowman JP. A reappraisal of the 21-day cumulative irritation test in man. J Toxicol Cut Ocular Toxicol 1982;1:109–115
  • Philips L, Steinberg M, Maibach HI, Akers WA. A comparison of rabbit and human skin response to certain irritants. Toxicol Appl Pharmacol 1972;21:369–382
  • Bowman JP, Berger RS, Mills OH, et al. The 21-day human cumulative irritation test can be reduced to 14 days without loss of sensitivity. J Cosmet Sci 2003;54:443–449
  • FDA Guidance for Industry. Skin irritation and sensitization testing of generic transdermal drug products. Washington, DC: CDER/FDA; 1999

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