Simulations Plus Releases GastroPlus™ Version 9.5

Keywords: antibody-drug conjugates (ADCs), bioequivalence trial, European Medicines Agency (EMA), in vitro-in vivo correlations (IVIVCs), PBPK modeling program, U.S. FDA
Software: GastroPlus®
Division: PBPK

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling & simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, today announced that it has released version 9.5 of its flagship PBPK modeling program, GastroPlus™.

Dr. Viera Lukacova, team leader and GastroPlus product manager, said: “This new version of GastroPlus is the result of many months of intense work by our talented simulation technologies team, and we are excited about the final outcome. A small sample of the many enhancements includes:

  • New PBPK models for antibody-drug conjugates (extension to the Biologics Module)
  • New models for subcutaneous and intramuscular injection formulations (extension to the Additional Dosage Routes Module)
  • Revamped workflows for building in vitro-in vivo correlations (IVIVCs) and performing virtual bioequivalence trial simulations (extension to the IVIVCPlus™ Module)
  • Several new physiology models, including Chinese and hepatic impairment population groups
  • Improved reporting capabilities, making it easier for companies wishing to submit results to regulatory agencies.”

John DiBella, vice president for marketing and sales for Simulations Plus, added: “GastroPlus has served as the industry’s workhorse software for oral drug development activities for many years, and we have invested heavily to extend the utility of the program to serve other research functions. We have also been fortunate to enter into several funded collaborations with industry and secure multiple grant awards from the U.S. FDA, which has resulted in the ongoing development of the Additional Dosage Routes Module that is now being licensed by numerous organizations. Version 9.5 has a mix of important new features that users across companies and departments will appreciate, and we expect this to drive further adoption of GastroPlus within the different markets we serve.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, said, “The cost and time to develop new drugs continues to increase, and simulation and modeling software is one of the most powerful productivity tools available to offset these rising costs. As a result of the recently released draft guidance documents focused on PBPK modeling from the U.S. FDA and the European Medicines Agency supporting the need for tools like GastroPlus to assist with pharmaceutical research and development, we believe adoption will only increase. Our focus on improving the reporting capabilities in this new version should allow sponsor companies to more effectively communicate results to regulatory authorities and, ultimately, to assist with the drug approval process.”