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CFSAN RCA

                                     

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MultiCASE Inc and Center for Food Safety and Applied Nutrition of FDA have signed Research Cooperative Agreement “Use of Collaborator’s Software to Develop Quantitative Structure-Activity Relationship (QSAR) Toxicity Models for CFSAN Regulatory Activities”.

 

The FDA and Multicase will work jointly under this 5-year Research Collaboration Agreement (RCA) to use Multicase’s software and scientific expertise and CFSAN’s scientific expertise to develop QSAR toxicity models for CFSAN regulatory activities. These models will provide scientific information to support the pre- and post-market evaluation of the safety of food additives and other substances within the jurisdiction of CFSAN. The models will enable CFSAN to estimate the potential toxicities of substances by correlating specific structural features of chemical molecules with specific toxicities that have been identified in standard in vitro and in vivo toxicological bioassays. These models facilitate early prioritization of potential chemical toxicities prior to human exposure, and they can be used for the prioritization of safety concerns for consumer products evaluated by CFSAN. During the term of the RCA, CFSAN and Multicase will make the software and models available to FDA scientists to provide information for regulatory and research decisions. Provisions also are made under this RCA for FDA’s continued access to the software and models after the term of the RCA. Where appropriate, the results of this RCA will be made available to the public through publications and presentations.

FDA Principal Investigator: Edwin J. Matthews Ph.D

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

FDA/CFSAN 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.