Following the signature of a Material Transfer Agreement, the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) and Prous Institute for Biomedical Research commence this month a joint study on the use of The BioEpisteme® Project in predicting drug-related toxicity in animals and adverse effects in humans.
The BioEpisteme® Project, a recent Prous Institute endeavor, is oriented towards the prediction of the pharmacological properties of molecules on the basis of their chemical structure. The technology has so far been successfully tested to build models to discriminate between active and inactive compounds for specific pharmacological activities, to differentiate drug from non-drug compounds, to build quantitative models for experimental pharmacology parameter determination and to provide indications about important 3D conformations for lead optimization. Additional ADMET properties can also be traced through the system with a high degree of accuracy.
The study, now under way by the FDA and Prous Institute, is to be completed within the next 12 months. It is a research effort to determine the utility and feasibility of using 3D conformations of molecules in making QSAR prediction of chemical activity. The objective is to establish the potency of BioEpisteme® technology at predicting drug-induced carcinogenicity. Carcinogenicity determination is important from a regulatory point of view owing to the cost and time necessary to develop experimental data. A standard two-year carcinogenicity study in rodents has an estimated cost of US $2 million. The successful application of BioEpisteme® technology to the prediction of drug-induced carcinogenicity could result in significant cost savings in drug development, as well as reduce the length of time needed to bring important new medications to market.
About the Center for Drug Evaluation and Research of the FDA
The US FDA's Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs sold in the United States are safe and effective. CDER evaluates all new drugs before they are sold, and serves as a consumer watchdog for the more than 10,000 drugs on the market to be sure they continue to meet the highest standards. The Center routinely monitors TV, radio, and print drug ads to ensure they are truthful and balanced. CDER also plays a critical role in providing health professionals and consumers information on how to use drugs appropriately and safely.
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