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FDA extends partnership with Certara

Certara, a specialist in simulation-enabled drug development, has announced that the US Food and Drug Administration’s (FDA) Center for Veterinary Medicine has extended a five year research agreement until 2020.

The five-year Cooperative Research and Development Agreement (CRADA) was setup to create physiologically-based pharmacokinetic (PBPK) canine models using Simcyp software – to help streamline veterinary drug development and evaluation.

Certara chief executive officer Edmundo Muniz, said: ‘The FDA values the additional insight and increased predictability provided by PBPK modelling when evaluating new drug candidates for animals and humans. Our Simcyp Simulator models can assess the effect of drug formulation and food on drug exposure in animals. These predictions can then be integrated with safety and effectiveness data to create more informative product labels.’

The FDA and Certara will focus their research efforts on exploring how drug absorption through the canine gastrointestinal tract and how this process is impacted by the presence or absence of food. They will also use the Simcyp Simulator to examine critical quality attributes that a drug formulation must possess to enable oral absorption by dogs. The FDA will also develop and test PBPK models for two more dog breeds.      

'Our canine computer models can help to improve the safety and efficacy of veterinary drugs. They can also reduce the need to include animals in the drug development process for human medications,’ added Steve Toon, president of Simcyp, a Certara company.

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 drug residues in food-producing animal species. In these situations, the Simcyp canine PBPK models can prove invaluable for assessing the potential impact of genetic variations between species on the resulting study data.


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