PBPK Predictions for Optimized Outcomes

When it comes to drug development, no one likes surprises.

You want to have the right data and insights at your fingertips to make informed decisions throughout the R&D process. Physiologically based pharmacokinetic (PBPK) modeling and simulation can help you anticipate likely outcomes for different scenarios, optimize your drug for the results you want, potentially waive expensive studies, and more.

Whether your in-house scientists are ready to leverage industry-leading PBPK software or you need PBPK/PBBM modeling support from our experts, we’re ready to help.

 

02. Software
PBPK Software

Our flagship PBPK modeling and simulation platform, GastroPlus®, is built by scientists who understand both the complex biology, chemistry, and physiology interactions and advanced computer science required for reliable predictions. For more than 25 years, we’ve continued to refine our algorithms and incorporate the latest scientific research to ensure confidence in your simulation results.

GastroPlus is a flexible platform that can accommodate your program needs, even as they change. Our wide range of available modules can expand your team’s ability to model your drug’s behavior in various animal and human populations, disease states, via different administration routes, in combination with other therapies, and more.

03. Modules
Our GastroPlus Software Suite

Industry-leading PBBM/PBPK modeling and simulation platform that simulates all major dosing routes and drug-drug interactions (DDI) in virtual animal and human populations.

A module that allows you to predict mechanistic and static DDIs among drugs and metabolites.

A module that allows for expanded simulation of distribution, elimination and concentrations of compounds throughout the body.

A module that enables you to obtain predictions from the structure of all physicochemical, pharmacokinetic and CYP metabolism kinetic parameters required for PBPK simulations.

A module that allows simulation of mechanistic absorption and disposition through dermal, intraoral, pulmonary, ocular, intramuscular and intraarticular routes.

A module that extends GastroPlus to include nonlinear pharmacokinetics into any compartment, along with metabolite tracking.

A module that simulates the systemic absorption and pharmacokinetics of biologics—for both monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs).

A module that automatically fits key parameters to the data, optimizes study designs and doses, and “deconvolutes” in vivo release profiles to achieve target concentration v. time curves for parents and/or metabolites.

A module that allows you to fit standard pharmacodynamic (PD) models to observed data and to then use the fitted models to predict PD effect changes due to changes in dose, dosage form, and dosing regimens.

A module for rapidly estimating pharmacokinetic (PK) parameters for noncompartmental analysis (NCA), along with 1-, 2-, & 3-compartment PK models from pharmacokinetic studies (IV and/or oral) without the need to run full simulations.

A module that allows you to develop mechanistic and/or traditional correlations (IVIVC) between either in vitro release and in vivo release or in vitro release and absolute bioavailability, then use the correlation to predict plasma concentration-time profiles for formulations with different in vitro release rates or dose strengths.

05. GastroPlus® Publications
Peer-reviewed Publications
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