食品和色素添加剂安全性评估中的药代动力学数据。

Pharmacokinetic data in the evaluation of the safety of food and color additives.

作者信息

Lin C S, Shoaf S E, Griffiths J C

机构信息

Division of Toxicological Review and Evaluation, Food and Drug Administration, Washington, D.C. 20204.

出版信息

Regul Toxicol Pharmacol. 1992 Feb;15(1):62-72. doi: 10.1016/0273-2300(92)90084-m.

DOI:10.1016/0273-2300(92)90084-m

PMID:1553413

Abstract

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.

摘要

供人类使用的食品和色素添加剂的安全性评估通常基于从动物研究中获得的毒性数据；人体数据很少能获取到。将动物数据外推至人类常常存在争议。药代动力学数据在食品和色素添加剂安全性评估中可能发挥的重要作用如今已得到广泛认可。本文综述了有关将设计合理的药代动力学研究应用于食品和色素添加剂安全性评估的当前科学知识。原则上，药代动力学数据不仅有助于设计、解释动物毒性研究并将其外推至人类，还能深入了解毒性机制。文中提供了此类应用的实例。