PBPK modeling software – from discovery through
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The GastroPlus™ PBPK modeling & simulation package – supporting internal research through regulatory interactions…

As a researcher in the life sciences space, you can’t measure everything as a project winds its way through the R&D process. With the data that is being generated, you’re expected to make informed decisions as quickly as possible. A wrong one sets you back severely, both in terms of time, money, and getting to market. Now, more than ever, it is important to consider incorporating new technology across your company – like PBPK modeling.

What if it were possible to:

  • Integrate the data which has been collected and, within the context of a virtual animal or human model, gain unique insights that improve your chances for success?
  • Run simulations for different scenarios to avoid costly surprises?
  • Utilize the outputs from these models to potentially waive expensive studies requested by regulatory agencies?

It’s possible to do this, and more, with the GastroPlus PBPK modeling platform.

GastroPlus is a mechanistically based simulation software package that simulates intravenous, oral, oral cavity, ocular, inhalation, dermal/subcutaneous, and intramuscular absorption, pharmacokinetics, and pharmacodynamics in humans and animals. This smoothly integrated platform combines a user-friendly interface with powerful science to help you make faster and more informed project decisions!

GastroPlus has been separated into modules to make it easier for companies to license only the features they need in each department. The 10 modules currently available are:

What are we providing with GastroPlus?

From the beginning, a conscious decision has been made to carefully implement the best theories and develop novel approaches within the GastroPlus PBPK models. This dedication to science is a major reason why our predictions are consistently ranked #1 in independent comparisons. You provide the (limited) data, GastroPlus provides everything else:

  • Simple, intuitive user interface
  • Model customization
  • High-quality plots & figures for reporting purposes
  • Excellent customer support
  • Thriving online GastroPlus User Group to connect users and provide an online forum for sharing best practices
  • Flexible licensing models. Ask us for more details.
  • Integration with our other tools. Seamlessly define inputs for your PBPK models using the top-rated quantitative structure-activity relationship (QSAR) models from ADMET Predictor™. Strengthen the in vitro-in vivo extrapolation of dissolution & absorption inputs with DDDPlus™ and MembranePlus™. And, inform quantitative systems pharmacology (QSP)/toxicology (QST) models to predict drug-induced liver injury (DILI) or non-alcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) – DILIsym® and NAFLDsym®

The in vivo processes which are considered in the GastroPlus simulations, and the methods we’ve introduced to parameterize them, are too numerous to list here – instead, take a peek at the GastroPlus datasheet for more details.

How is GastroPlus being applied?

The GastroPlus PBPK modeling platform has been utilized by companies across various industries and departments since 1998. Some of the routine applications include:

  • Screening compound libraries through the QSAR/PBPK marriage to prioritize in vivo testing
  • Predicting first-in-human (FIH)/animal doses with best-in-class IVIVE methods
  • Supporting animal or human risk assessment studies
  • Simulating steady-state and dynamic drug-drug interactions (DDI) for regulatory submissions
  • Building PBPK/PD models to estimate efficacious dose levels
  • Assisting with Quality by Design (QbD) implementation to define product specifications
  • Deconvoluting in vivo dissolution for mechanistic IVIVCs
  • Understanding food effect differences
  • Conducting virtual population PK/PBPK studies & bioequivalence trials
  • Identifying appropriate dose levels and dosing regimens in diseased/pediatric populations
  • … and more!

Read about various case studies by scanning the peer-reviewed publication list! Or, have a project that would benefit from GastroPlus modeling but do not have the expertise in-house to utilize it? Schedule a call with one of our consulting experts today!

What's new in GastroPlus v9.6?

There’s something for everyone in GastroPlus v9.6, including:

  • New dynamic fluid options added to the #1-ranked ACAT™ oral absorption model
  • New QSAR model predictions of rat-specific properties (intrinsic clearance, plasma protein binding, blood:plasma concentration ratio) and Extended Clearance Classification System (ECCS) with the ADMET Predictor™ Module
  • Expanded enzyme/transporter distribution information in the Metabolism and Transporter Module for easier extrapolation across species
  • Upgraded capabilities to all major mechanistic absorption routes, including dermal, pulmonary, ocular, and subcutaneous/intramuscular injections – available in the Additional Dosage Routes Module
  • New whole-body physiology models for obesity and renal impairment disease groups in the PBPKPlus™ Module
  • Significant simulation speed improvements
  • Upgraded reporting capabilities for all simulation modes, including Batch, Parameter Sensitivity Analysis, and Population Simulator™ – easier interpretation for regulatory submissions
  • New PBPK models for standard substrates and inhibitors in the DDI Module
  • Enhanced parameter covariate models in the Population Simulator™
  • Additional deconvolution and correlation functions for generation of mechanistic in vitro-in vivo correlations (IVIVCs) with the IVIVCPlus™ Module
  • Improved custom template generation for seamless use of GastroPlus to drive DILIsym® SimPops™ liver injury predictions
  • … and more!

View the full GastroPlus release notes.

GastroPlus version 9.6 is now available for download – instructions can be found here!

GastroPlus v9.6 patch is now available here!

How do I move forward from here?

Join your peers around the world and begin working with GastroPlus to support internal research projects and regulatory interactions.

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