Certara expands partnership with FDA for canine drug development

Medicine in vials

New Jersey-based biosimulation firm Certara and the FDA like working together so much, they’re expanding their relationship. The pair will team up through 2020 to create new canine computer models to evaluate drugs for dogs.

Certara and the FDA’s Center for Veterinary Medicine already had a 5-year deal in place. The latest pact will allow the company and agency to fine tune physiologically-based pharmacokinetic (PBPK) canine models.

The models will help create better drugs for dogs by determining how meds are absorbed through the canine gastrointestinal tract. The technology will also show how a drug’s formulation can affect how well a dog absorbs the med.

“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,” Certara CEO Edmundo Muniz said in a statement.

Certara and the FDA will also develop and test PBPK models for two more dog breeds, the Princeton, NJ-based company said.

The technology could have far-reaching benefits, as models could be used in place of animals during drug development for human meds, Steve Toon, president of Certara’s Simcyp, said in a statement.

It’s been a busy year for Certara. In January, the company launched a new business, Certara Strategic Consulting China, in Shanghai. The move was meant to expand Certara’s global footprint and help it cash in on China’s rapidly growing healthcare market.

“Biosimulation is an innovation that will not only expedite bringing safer therapies to market, but also will support China's expansion of its fast-track drug approval process. We are delighted to be able to provide biosimulation consulting support for our clients in China," Muniz said in a statement at the time.

- here’s the statement

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