Validation and Regulatory Acceptance of Alternatives

Cambridge Quarterly of Healthcare Ethics 8 (1):73-79 (1999)
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Abstract

For years there was no focus within the U.S. federal government for alternatives to animal toxicity testing. Questions coming to regulatory agencies fell upon individuals to address in the best way they could. Given this void, the ad hoc Interagency Regulatory Alternatives Group was founded by staff in a number of federal agencies in the late 1980s to coalesce efforts in the field. The group sponsored two international workshops on eye irritation, the first making proposals for change in the current test method in rabbits, the second reviewing available data on in vitro alternatives. The result has been that the Organization for Economic Cooperation and Development (OECD) is considering revision of the in vivo eye irritation test guideline to incorporate a number of the workshop deliberations. However, movement of the in vitro eye irritation alternatives has been disappointing; attempts to determine their practical testing significance have thus far been unrewarding

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