Anticaries fluoride bioavailability alternative test method proposed by Tom's of Maine.
This article was originally published in The Rose Sheet
Executive Summary
ANTICARIES FLUORIDE BIOAVAILABILITY ALTERNATIVE TESTING PROCEDURE PROPOSED by Tom's of Maine to meet biological test requirements for fluoride dentifrice drug products in the OTC anticaries final monograph. In a Feb. 16 citizen petition, the natural toothpaste marketer asked that FDA accept data from an "intra-oral remineralization test in human subjects" as a replacement for the animal caries reduction test specified in the monograph.
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