
GastroPlus is a leading modeling and simulation software for physiologically-based pharmacokinetics (PBPK) and biopharmaceutics (PBBM), supporting drug development from early research to regulatory filings.
Vendor
Simulations Plus
Company Website
GastroPlus® is a comprehensive modeling and simulation package designed for scientists and researchers in the pharmaceutical and chemical industries. It supports the entire drug development lifecycle, from internal research to critical regulatory submissions. The software is built upon carefully implemented theories and novel approaches in PBPK and PBBM models, consistently delivering highly-ranked predictions in independent comparisons. It enables users to simulate and predict various properties of drugs and chemicals, including absorption, release rate, bioavailability, pharmacokinetics (PK), and pharmacodynamics (PD). The platform facilitates the prediction of drug-to-drug interactions (DDI), drug effects on animals, and virtual patient populations. Researchers can adjust pharmacodynamic models to observed data, then use these fitted models to predict changes in pharmacodynamic responses based on modifications to dose, dosage form, or dosing regimen. GastroPlus also supports the generation of in vitro-in vivo correlations (IVIVC) and the prediction of absorption and systemic distribution/elimination for large molecules, such as biologics. Its intuitive user interface and ability to generate high-quality plots and figures make it suitable for reporting purposes.
Features & Benefits
- Comprehensive Drug & Chemical Modeling
- Simulates and predicts properties of drugs and chemicals including absorption, release rate, bioavailability, pharmacokinetics (PK), and pharmacodynamics (PD).
- Physiologically-Based Pharmacokinetics (PBPK) & Biopharmaceutics Modeling (PBBM)
- Utilizes advanced PBPK and PBBM models for accurate predictions, covering physiology creation, Kp calculations, and species scaling.
- Drug-Drug Interaction (DDI) Prediction
- Allows for the prediction of drug-to-drug interactions, crucial for drug safety and efficacy assessments.
- Virtual Population & Animal Studies
- Enables the prediction of drug effects on animals and virtual patient populations, reducing the need for extensive in vivo studies.
- Pharmacodynamic Model Adjustment & Prediction
- Adjusts pharmacodynamic models to observed data and predicts changes due to modifications in dose, dosage form, and dosing regimen.
- In Vitro-In Vivo Correlation (IVIVC) Generation
- Supports the generation of in vitro-in vivo correlations for better understanding of drug performance.
- Large Molecule (Biologics) Modeling
- Predicts absorption and systemic distribution/elimination for large molecules, incorporating concepts like FcRn and TMDD.
- Formulation Optimization (via DDDPlus™)
- Covers key concepts for optimizing drug product performance, including solubility versus pH, particle size effects, biorelevant solubility, precipitation modeling, extended-release formulations, and surfactant media dissolution.
- Integration with Simulations Plus Ecosystem
- Seamlessly defines inputs for PBPK & PBBM models using ADMET Predictor®, strengthens in vitro-in vivo extrapolation with DDDPlus™ and MembranePlus™, and informs QSP & QST models like DILIsym® and NAFLDsym®.
- Intuitive User Interface & Reporting
- Provides a simple, intuitive user interface and generates high-quality plots and figures suitable for reporting purposes.