Simcyp Signs Collaborative Research Agreement with US FDA to Extend Dog Simulator to Veterinary Medicines

Simcyp (now 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.

Simcyp already provides an animal PBPK simulator, based on the Simcyp Population-based Simulator, for the beagle dog, rat and knock-out mouse. Human PBPK modelling is now increasingly used by both drug sponsors and regulatory agencies to smooth the regulatory process by facilitating decisions on the necessity of specific clinical pharmacology studies, to inform study design and aid with appropriate labelling language.

Professor Amin Rostami-Hodjegan, Vice President of Scientific Research and Development at Simcyp, said: “In the absence of specific studies in individual breeds of dog which would take into account genetic variations between breeds, individual dose requirements can be evaluated in ‘virtual dog models’ built for each species. We are delighted that the technologies developed by our group to assess human genetic variations have been picked up by the scientists within the FDA veterinary group for application in this field.”

About Simcyp

Simcyp provides platforms for the modelling and simulation of pharmacokinetics and pharmacodynamics in virtual human populations and virtual laboratory animals (rat, dog & mouse). The technology allows pharmaceutical researchers to predict in vivo outcomes from routinely generated in vitro data, to fit Simcyp models to observed clinical data and to assess inter-individual variability through ‘real-life’ simulations. Simcyp also runs educational workshops and provides strategic consultancy in drug development.

About Certara

Certara is dedicated to improving human health through a broad spectrum of software products and consulting services that enable model-based drug development. Certara was formed by uniting industry leaders Tripos®, provider of innovative scientific software solutions and services enabling life science researchers to improve the efficiency of molecular discovery; Simcyp®, a research-based company providing predictive pharmacokinetic and pharmacodynamics tools, workshops, and consultancy services; and Pharsight® Corporation, provider of software and scientific consulting services to improve productivity and decision-making in preclinical and clinical drug development.

Each Certara family brand has a primary focus and expertise in enabling model-based drug development in a key phase within the drug discovery and development process; combined, they offer a unique set of capabilities for modeling, analysis, and simulation with scientific informatics that can enable the cross-disciplinary approaches necessary for translational science initiatives.