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Anticaries test alternatives

Executive Summary

Inclusion of validated in vitro pH cycling model in the OTC Anticaries Products Monograph as alternative to animal caries testing is urged by Procter & Gamble. Intraoral Appliance model, a non-animal test method currently under review by FDA, is an important research tool, but should not be included in the anticaries monograph due to "considerable model heterogeneity, lack of validation data and lack of reliability," company maintains in recent comments to agency. P&G is "firmly committed" to developing testing alternatives to animal caries model, firm notes. CTFA/CHPA have encouraged FDA to evaluate multiple alternative test methods in joint comments to the agency (1"The Rose Sheet" July 22, 2002, p. 8). Comments were submitted in response to FDA's request for data on the IOA model in October (2"The Rose Sheet" Oct. 22, 2001, p. 7)...
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