Evaluating the safety of food and color additives with pharmacokinetic data.
Pharmacokinetic studies are designed to quantify, as a function of time, the processes associated with absorption, distribution, metabolism, and excretion of a chemical in experimental animals or in humans. Such studies have played an important role in drug safety evaluation and could be very useful in the safety evaluation of food and color additives. This presentation provides an overview of the potential use of metabolic and pharmacokinetic data in the design and evaluation of toxicological studies and in the assessment of the potential hazard to humans from exposure to food or color additives.
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Division of Toxicological Review and Evaluation, Food and Drug Administration, Washington, D.C. 20204.
D000818:Animals; D003257:Consumer Product Safety; D005503:Food Additives / Q000493:pharmacokinetics* / Q000633:toxicity; D005505:Food Coloring Agents / Q000493:pharmacokinetics* / Q000633:toxicity; D006801:Humans
D005503:Food Additives; D005505:Food Coloring Agents