Vanparys Philippe
Department of Genetic and In Vitro Toxicology, Johnson & Johnson Pharmaceutical Research & Development (a Division of Janssen Pharmaceutica NV), Turnhoutseweg 30, 2340 Beerse, Belgium.
Altern Lab Anim. 2002 Dec;30 Suppl 2:221-3. doi: 10.1177/026119290203002S37.
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.
在制药行业，毒理学测试通常由临床前科学家在研发阶段进行。在过去十年中，发现阶段高通量筛选的实施导致越来越多的潜在先导化合物被选入药物研发。传统安全性测试的低通量是药物研发过程中的一个瓶颈。制药行业需要新技术、缩微测试和体外替代测试模型，以在发现阶段后期和/或研发阶段早期确定化合物的吸收、分布、代谢和排泄（ADME）以及毒理学特征。中通量ADME和毒性测试将加强对更安全的新化学实体用于动物和/或人类的筛选。因此，这种测试策略不仅将减少资源使用和整体研发时间，还将大幅减少动物使用量。
