Simulations Plus Upgrades Flagship GastroPlus

Keywords: dermal absorption, drug-drug interactions (DDIs), fed state simulation, lysosomal trapping, mechanistic pregnancy, PBPK modeling program, solubility
Software: GastroPlus®
Division: PBPK

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 released version 9.7 of its flagship physiologically based pharmacokinetic (PBPK) modeling platform, GastroPlus®.

Key improvements in this version include:

  • Ability to add lysosomal trapping effects to PBPK tissues for more accurate systemic calculations
  • New mechanistic pregnancy PBPK model with integrated population settings
  • Options to define multiple solubility inputs for different drug forms
  • Expanded fed state simulation conditions based on defined meal types
  • Validated models of standard compounds added to the drug-drug interaction (DDI) Module
  • PK/PD model extensions added to the PDPlus™ Module
  • Improved population groups for extensive, intermediate, and poor metabolizers based on specific genotypes
  • Updates to the dermal absorption (TCAT™) model through the Cosmetics Europe collaboration
  • Novel effects of immune response added to the intramuscular injection models
  • And more…

“Special populations modeling continues to be a key component of GastroPlus with numerous companies applying the results to support regulatory interactions,” said Dr. Viera Lukacova, director of Simulation Sciences for Simulations Plus. “With this release, we have added several new groups, including a validated mechanistic pregnancy model, which will greatly enhance the understanding of drug exposure and assist with dose selection decisions. Special thanks to the dedicated scientific team at Simulations Plus and our collaboration partners for all their outstanding efforts.”

John DiBella, Lancaster division president for Simulations Plus, added: “GastroPlus continues to provide researchers, including chemists, DMPK scientists, pharmaceutical developers, and clinical pharmacologists, a proven and flexible PBPK software to support safety and efficacy decisions, first-in-human estimations, formulation optimization, and drug-drug interaction assessments. For over twenty years, Simulations Plus has been dedicated to improving our state-of-the-art tools, and the significant enhancements that are integrated in version 9.7 are just a preview of exciting advancements that will be the foundation for next year’s entirely new platform release of GastroPlus.”