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FDA-Simcyp CRADA

Through Simcyp, Certara has entered into a Cooperative Research and Development Agreement (CRADA) with the US Food and Drug Administration (FDA) to further develop the Simcyp Dog model for the evaluation of drug products intended for use in different canine breeds.

This five year project, in conjunction with researchers at the FDA’s Center for Veterinary Medicine (CVM), aims to deliver physiologically-based pharmacokinetic (PBPK) dog models intended to help streamline the process of veterinary drug product development and evaluation. This will be accomplished by facilitating the use of pharmacokinetic principles as a tool for addressing complex questions associated with the design and interpretation of target animals safety studies and clinical field studies and by enabling the integration of model predictions with data from safety and effectiveness studies to support the development of informative product labels.

In addition to their importance as a companion animal species, dogs are frequently used as a preclinical species to support human drug development or as a toxicological species when evaluating the human safety of drugs residues in food-producing animal species. In both situations, the Simcyp canine PBPK models can be invaluable for assessing the potential impact of polymorphic variations on the interspecies extrapolation of the resulting study data.