21. Application of computational toxicology (ComTox) and multicase (MCASE) software to the FDA Mission. Edwin J. Matthews, and Joseph F. Contrera, FDA's Office of Testing and Research (OTR), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857, Fax: 301-827-3787, firstname.lastname@example.org
Under a CRADA between FDA and Multicase, Inc., new ComTox software programs have been developed that estimate chemical-toxic responses and dosages in animals using animal toxicology studies, and in humans using pre-market clinical-trial data and post-market adverse-event data for pharmaceuticals. This talk will examine two software modules that predict the potential carcinogenicity, and the maximum-tolerated-dose (MTD), in rats and mice, and it will elaborate on the experimental parameters that were accounted for the program's high predictive performance and excellent coverage for FDA-regulated substances. The parameters include: (1) large control data sets (n1000), (2) separate modules for each study cell ( / rat & mouse), (3) the use of biological potency scales, and (4) a human expert system. The talk will also review the current and future regulatory applications of ComTox within the Agency.