ATLA::Alternatives to Laboratory Animals

Volume 30, Supplement 2

ECVAM and pharmaceuticals

ATLA 30, Supplement 2, 221-223, 2002

Philippe Vanparys

Department of Genetic and In Vitro Toxicology, Johnson & Johnson Pharmaceutical Research & Development (a Division of Janssen Pharmaceutica NV), Turnhoutseweg 30, 2340 Beerse, Belgium

SUMMARY

In the pharmaceutical industry, toxicology testing is normally done by preclinical scientists during the Development phase. In the last decade, the implementation of high-throughput screens during the Discovery phase has resulted in an ever-increasing number of lead candidates to be selected for drug development. The low throughput of the conventional safety tests is a bottleneck in the drug-development process. The pharmaceutical industry needs new techniques, down-scaled tests and in vitro alternative test models to determine the absorption, distribution, metabolism, and excretion (ADME) and toxicology profiles of compounds in the late-Discovery phase and/or early in the Development phase. Medium-throughput ADME and toxicity tests will enhance the selection of safer new chemical entities for animals and/or humans. Consequently, this testing strategy will not only reduce the use of resources and the overall development time, but will also result in a substantial decrease in animal use.

Keywords: alternatives, animal testing, drug discovery, preclinical toxicology