2008 - Marseille - France

PAGE 2008: Software demonstration
Viera Lukacova



SimulationsPlus, Inc.

GastroPlusTM is the gold standard in the pharmaceutical industry for simulation of gastrointestinal absorption, pharmacokinetics, and pharmacodynamics. The program can simulate, and fit models with, any combination of oral and intravenous doses in humans and animals, including fasted and fed states for human and several laboratory animals. Version 6.0 now expands on the well-established capabilities and user-friendliness of this powerful tool.

  • The industry's most advanced gastrointestinal absorption simulation
    • Local pH effects on lipophilicity, solubility, permeability, and dissolution/precipitation
    • Comprehensive formulation options for both immediate release and controlled release dosage forms, including dissolution rates for different particle sizes
    • Mixed multiple doses - any combination of iv and peroral (PO) doses of arbitrary amounts at arbitrary times
    • Fasted and fed states, with the ability to switch between them at any time
    • Degradation as a function of pH in the lumen
  • Pharmacokinetics options include
    • The industry's most advanced and user-friendly PBPK and PBPK/PD modeling capability
    • Built-in PEAR Physiology (with PBPKPlus module) generates realistic virtual individuals or populations using NHANES and Japanese databases for Western and Asian populations
    • Up to 3-compartment conventional pharmacokinetics including effects of first pass extraction, blood cell binding, and plasma protein binding.
    • Metabolite tracking, including metabolites of metabolites
    • Saturable metabolism and transport in gut and any other tissue(s)
    • Virtual Trials allows estimating pharmacokinetic variations in populations specified by ethnicity (Western or Asian), gender ratio, and age range.
  • Pharmacodynamics options include
    • Standard direct and indirect models fitted to plasma or (with PBPK) tissue concentrations
    • Assessment of individual model parameters on PD effects via Parameter Sensitivity Analysis
    • Virtual Trials allows estimating pharmacodynamic variations in populations specified by ethnicity (Western or Asian), gender ratio, and age range.
  • A variety of program output formats accommodate how your company works.

Ask for a free evaluation CD and an on-line tutorial session to help you evaluate the benefits of GastroPlus in your work.

Reference: PAGE 17 (2008) Abstr 1423 [www.page-meeting.org/?abstract=1423]
Software demonstration