The Center for Alternatives to Animal Testing is an academic center affiliated with the Division of Toxicological Sciences in the Department of Environmental Health Sciences of the Johns Hopkins University Bloomberg School of Public Health.

 

Johns Hopkins School of Public Health

Abstract for TestSmart--Pharmaceuticals: An Efficient and Humane Approach to Predictors of Potential Toxic Effects of Drugs

ADME-Tox Testing with in vitro Human Experimental Systems

Albert P. Li
In Vitro Technologies, Inc.

Absorption, disposition, metabolism, elimination and toxicity (ADME-Tox) are critical drug properties that are found to be responsible for the high incidence of failure of drug candidates in clinical trials. Traditionally, ADME-Tox evaluation is performed in laboratory animals. This high incidence of failure illustrates the difficulty in the prediction of human drug properties using nonhuman animal experimental models. One approach to bridge the knowledge-gap between laboratory and human is to use in vitro human-based experimental systems. The in vitro human experimental systems that are established include the Caco-2 culture for the evaluation of intestinal absorption and human hepatic systems such as hepatocytes for drug metabolism, toxicity, and drug-drug interaction studies. The use of human in vitro systems should aid the reduction of the use of animals, help refine the use of animals, and in some cases, replace the use of animals in the evaluation of ADME-Tox properties of chemicals intended to be used as human pharmaceuticals.