Simulations Plus Enters into New Research Collaboration Agreement with the FDA

Software: GastroPlus®
Division: Simulations Plus

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new five-year Research Collaboration Agreement with the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine to evaluate alternative approaches for determining product bioequivalence (BE) for locally-acting drugs in animals.

“It is always exciting to announce ground-breaking collaborations with the FDA and reinforce our partnership as we advance science in new areas,” said Viera Lukacova, director of Simulation Sciences for Simulations Plus and principal investigator on the project. “Under this agreement, the FDA, using GastroPlus with in vitro and in vivo data, will investigate how BE 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.”

John DiBella, Lancaster division president for Simulations Plus, added, “Our technology is already assisting companies and regulatory agencies with the ‘3 Rs’: reducing, replacing, and/or refining animal use. 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 to support biowaiver applications.”

Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.