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Simulations Plus, FDA form research agreement

Simulations Plus and the US Food and Drug Administration (FDA) have formed a five-year research collaboration agreement (RCA), under which both the parties will jointly work for the development of Quantitative Structure-Activity Relationship (QSAR) toxicity models for FDA regulatory and research applications.

As per the terms of the agreement, the FDA will offer non-proprietary toxicology data for a variety of toxicological endpoints: including, carcinogenicity, developmental toxicity, genetic toxicity, and reproductive toxicity.

Simulations Plus and FDA scientists will use Simulations Plus’ ADMET Predictor/Modeler software to build and validate the predictive QSAR models, and these models will be incorporated into ADMET Predictor.

The agreement allows Simulations Plus to commercialize the QSAR models that are developed under the collaboration.

Simulations Plus chairman and CEO Walt Woltosz said their property prediction program, ADMET Predictor, will be enhanced further with the availability of the toxicity models they will develop under this collaboration and will provide the FDA with new tools to assist in their evaluation of food additives and contaminants to enhance public safety.