Anticaries Alternative Test Review Should Include Multiple Methods – CTFA
This article was originally published in The Rose Sheet
Executive Summary
FDA should evaluate multiple alternative test methods in addition to the Intraoral Appliance (IOA) model as it considers non-animal test methods for OTC anticaries products, the Cosmetic, Toiletry and Fragrance Association and Consumer Healthcare Products Association Joint Anticaries Task Group says
You may also be interested in...
Anticaries test alternatives
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)...
Anticaries test alternatives
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)...
IOA Anticaries Test Alternative To Be Reviewed By FDA Advisory Committee
An FDA advisory committee will explore whether or not the Intraoral Appliance (IOA) model should be permitted in place of animal caries studies currently required in the OTC anticaries monograph, FDA says in a 1March 15 Federal Register notice