Alternative Method Validation

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The term "alternatives" was coined by the distinguished physiologist David Smyth in his 1978 book Alternatives to Animal Experiments. It is used to describe any change to established scientific procedures that will result in the replacement of animals, a reduction in the numbers of animals used, or a refinement of techniques that may minimize harms to the animals. Therefore, Smyth's term "alternatives" is synonymous with Russell and Burch's Three Rs.

For regulatory testing purposes, an alternative method must undergo validation before it can replace an existing method (validation refers to the process of proving that a test method is acceptable for its intended purpose). The major steps for replacing an existing regulatory test with a new method are:

  • development of the test (possibly preceded by basic research)
  • prevalidation
  • validation
  • peer review/independent assessment
  • regulatory acceptance

This section has been adapted from AltTox, Non-animal Methods for Toxicity Testing, website.