FDA extends its Cooperative Research and Development Agreement with Certara until 2020
PRINCETON, NJ – 2016 年 06 月 8 日 – Certara®, the global biosimulation technology-enabled drug development company, today announced that the US Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine has extended its five-year Cooperative Research and Development Agreement (CRADA) with the company until 2020. Certara is partnering with the FDA to create additional Simcyp® physiologically-based pharmacokinetic (PBPK) canine models to help streamline veterinary drug development and evaluation.
“The FDA values the additional insight and increased predictability provided by PBPK modeling when evaluating new drug candidates for animals and humans,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “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.”
FDA and Certara will now focus their research efforts on exploring how drug absorption through the canine gastrointestinal tract 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. In addition, they will develop and test PBPK models for two more dog breeds.
“Our sophisticated 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, BPharm, PhD, 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.
PK principles can also be used to address complex questions related to the design and interpretation of target animal safety studies and clinical field studies.
Certara is a global biosimulation and regulatory writing company, committed to optimizing drug development decisions. Its clients include hundreds of international biopharmaceutical companies, leading academic institutions, and key regulatory agencies. Certara’s solutions, which span drug discovery through patient care, increase the probability of regulatory and commercial success by using the most scientifically-advanced modeling and simulation technologies and regulatory strategies.
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions