title: The need for a formal invalidation process for animal and non-animal tests.
abstract: A plethora of regulations require that many chemicals and chemical products are tested for efficacy and/or toxicity. When permitted to operate effectively and without bias, the ECVAM/ICCVAM/OECD validation process can be used to independently establish that new animal and non-animal test procedures are sufficiently relevant and reliable for their stated purposes and should be considered for regulatory use. However, the validation process is under threat because of vested interests of various kinds, and it is clear that many currently-accepted animal tests and candidate animal and non-animal tests do not, and could never, meet the agreed criteria for necessity, test development, prevalidation, validation and acceptance. We therefore need an invalidation process to parallel and protect the validation process, so that such methods could be independently reviewed and declared irrelevant and/or unreliable for their claimed purposes. An additional advantage of such a process would be that valuable resources would no longer be wasted in attempts to secure the acceptance of inherently inadequate tests.
authors.affiliation: FRAME, Nottingham, UK. michael.balls@btopenworld.com
authors.forename: Michael
authors.initials: M
authors.lastname: Balls
authors.forename: Robert
authors.initials: R
authors.lastname: Combes
mesh_terms: D023401:Animal Use Alternatives / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards*; D000818:Animals; D005062:European Union; D006801:Humans; D066298:In Vitro Techniques; D015203:Reproducibility of Results; D018675:Toxicity Tests / Q000379:methods / Q000592:standards*; D015262:Xenobiotics / Q000145:classification / Q000633:toxicity*
chemical_list: D015262:Xenobiotics