MultiCASE Inc and Center for Drug Evaluation and Research of FDA have signed Research Cooperative Agreement “Enhancement of In Silico Decision Support Tools for the  Evaluation of Drug Safety”.

The FDA and MultiCASE Inc. will work jointly under this 5-year research collaboration agreement (RCA) to develop and improve new and existing in silico models for use as decision support tools in drug safety assessment. These models will assess the safety of drug candidates at toxicological and clinical endpoints of regulatory relevance to CDER, based on an advanced analysis of molecular structure (quantitative structure-activity relationship). Both parties will hold joint research meetings and, where appropriate, make results of the collaboration publicly available through publications and public presentations.

FDA Principal Investigator: Naomi L. Kruhlak, Ph.D.

Collaborator Principal Investigator: Roustem D. Saiakhov, Ph.D.

FDA/CDER has access to MultiCASE software under this RCA

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Copyright © 2011 Multicase Inc
Last modified: 08/01/11

MultiCASE MC4PC-based computational toxicology estimations are intended to be used as part of a weight of evidence approach for hazard and risk assessment that includes laboratory experimental data. Computational toxicology predictions are not intended as a substitute for appropriate animal or clinical studies. Results obtained with certain MC4PC software modules should be regarded as preliminary and subject to change.