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Saturday, May 21, 2022

How Effective is That Dog Drug Off the Shelf?

Simulations Plus Inc. has entered into a five-year research collaboration agreement with the Food and Drug Administration’s Center for Veterinary Medicine to test drug efficacy in animals. The Lancaster drug simulation company said the FDA will use its GastroPlus software to assess “product bioequivalence” in dogs to see if one drug is more efficient than another in producing the desired result. “It is always exciting to announce ground-breaking collaborations with the FDA and reinforce our partnership as we advance science in new areas,” Viera Lukacova, director of Simulation Sciences for Simulations Plus and principal investigator on the project, said in a statement. “Under this agreement, the FDA, using GastroPlus with in vitro and in vivo data, will investigate how (bioequivalence) of non-systemically absorbed products can be evaluated in canines without the need for clinical endpoint trials. Ideally, through verification of the methods and results, a framework can be provided to support these approaches for other drugs,” she added. In vitro and in vivo refer to medical procedure techniques either outside a living organism, in vitro, versus testing on a living subject, in vivo. Veterinary medicine and animal health organizations already license out Simulations Plus technology to support research and development efforts, the company said. For this particular partnership, Simulations Plus will test two drugs available for dogs: ivermectin, which treats parasite infestations, and praziquantel, used as an anti-worm medication. Past partnerships have focused more on human clinical development activities. Virtual animal models will be emphasized in the GastroPlus platform used in research efforts. “Our technology is already assisting companies and regulatory agencies with the ‘3 Rs’: reducing, replacing and refining animal use,” said John DiBella, president for Simulations Plus’ Lancaster division. “We look forward to these interactions with the FDA staff to better understand model performance on additional veterinary medicines and identify further advances to the GastroPlus platform.” “The FDA looks for opportunities to continue to collaborate with the private sector, academia or other partners with specific expertise in order to expand the available tools to evaluate the safety and effectiveness of animal drugs,” said an FDA spokesperson. “In this case, partnering harnesses the power of computer-based modeling and simulation as a complement to the laboratory-based components of research work ongoing at the FDA.”

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