Lin C S, Shoaf S E, Griffiths J C
Division of Toxicological Review and Evaluation, Food and Drug Administration, Washington, D.C. 20204.
Regul Toxicol Pharmacol. 1992 Feb;15(1):62-72. doi: 10.1016/0273-2300(92)90084-m.
Safety evaluation of food and color additives intended for human use is usually based on toxicity data obtained from animal studies; human data are rarely available. The extrapolation of animal data to humans is often controversial. The important role that pharmacokinetic data could play in the safety evaluation of food and color additives is now widely recognized. This paper reviews the current scientific knowledge concerning the application of properly designed pharmacokinetic studies to the evaluation of the safety of food and color additives. In principle, pharmacokinetic data can be useful not only in designing, interpreting, and extrapolating animal toxicity studies to humans, but also in providing insight into the mechanisms of toxicity. Examples of such applications are provided.
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