GastroPlus enables innovators across the drug lifecycle to confidently explore and gain critical understanding, transforming complex questions into data-driven, regulatory-ready insights.

With GastroPlus, you can:

  • Make predictions from structure to drive chemistry and prioritize experiments 
  • Conduct preclinical verification and translation to human in a single integrated platform 
  • Define first-in-human (FIH) dose strategies grounded in mechanistic science 
  • Anticipate food effects and optimize formulation strategies before costly studies 
  • Quantify drug-drug interaction risk with defensible regulatory justification 
  • Support biowaivers and reduce unnecessary clinical burden 
  • Conduct virtual bioequivalence and population simulations to de-risk programs 
A confident Simulations Plus scientist wearing a lab coat with Career Center emblem crosses arms of model-informed drug development

Turn regulatory expectations
into competitive advantage
A world map with key regulatory agencies' acronyms highlights Simulations Plus PBPK modeling.

Regulatory agencies increasingly expect MIDD to be integrated early, assumptions documented transparently, and conclusions grounded in reproducible science. Those expectations demand more than isolated analyses.

GastroPlus brings your data into a unified, mechanistic PBPK/PBBM framework, connecting ADME properties, in vitro results, formulation inputs, and physiology within a validated scientific engine. The result is critical thinking and clarity throughout the development process: stronger dose rationale, fewer avoidable studies, and submissions built on defensible, traceable modeling.

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See the ROI of model-informed
drug development
How one client used GastroPlus®
PBPK modeling to avoid a DDI
clinical study
 
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How one client used GastroPlus®
PBPK modeling to justify wider
dissolution specifications and
achieve 12x ROI
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How one client used GastroPlus®
PBPK modeling to predict
bioequivalence and save four
months of study time
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Streamline PBPK/PBBM workflows
across your organization

GastroPlus offers more than just powerful PBPK/PBBM modeling—it supports the modeler, too. You can:

  • Ask technical and operational questions and receive instant answers from AI-powered assistants 
  • Leverage intelligent model setup guidance and diagnostic suggestions to optimize predictive performance 
  • Utilize embedded expert knowledge to gain advice on your specific compound or simulation 
  • Run simultaneous simulations to quickly evaluate wide parameter spaces 
  • Automate custom and/or complex workflows so they run with a single click 

Whether it’s part of your existing workflow or integrated through our REST API, it’s easy to connect your data and our models to generate reliable PBPK/PBBM predictions. You can use GastroPlus as part of your organization’s complete drug development lifecycle—from discovery with ADMET Predictor®, through development with MonolixSuite™ and DILIsym®, and into clinical operations with Pro-ficiency®.

GastroPlus Features and Modules

GastroPlus is highly configurable based on the work you do. Extended functionality is available when you need it.

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2000+
peer reviewed publications

See how industry colleagues are using GastroPlus across the R&D lifecycle.

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Resources

Training
Training

Instructor-led and on-demand courses to build your PBPK modeling expertise

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Documentation
Documentation

User guides, tutorials, and technical references to help you succeed

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GastroPlus User Group
GastroPlus User Group

Connect with peers, share insights, and stay up to date on the latest.

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Webinars and Events
Webinars and Events

Join expert-led webinars and events.

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