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The Power of Using a Single PBPK Modeling and Simulation Platform

Authors: Kilford P
Keywords: gastroplus, GastroPlus X, GPx, PBPK modeling
Software: GastroPlus®
Division: PBPK

Physiologically-based pharmacokinetic (PBPK) modeling is now a standard tool used across the pharmaceutical industry to increase understanding of a drug’s behavior in the body and to help guide its development. Despite being standard, it still has challenges, including unnecessary ones that arise when different PBPK tools are utilized at different stages of a drug’s lifecycle.

In this post, we delve into the advantages of employing a single PBPK modeling platform throughout the entire drug development lifecycle, mitigating potential problems encountered with multiple tools.

The Pitfalls of Using Different PBPK Tools

1. Integration Hurdles

When different PBPK tools are used across different phases of the drug development paradigm, integrating model outputs can become a challenging task. Different data formats, incompatible model structures, and reporting differences can prevent seamless data evaluation. This fragmentation can lead to inefficiencies, errors, and inconsistencies, thereby slowing down the decision-making processes.

2. Workflow Disruption

Transitioning between different PBPK platforms disrupts the workflow of our busy modeling and simulation teams. Modelers must acclimate to distinct graphical user interfaces, functionalities, methodologies, and ways of inputting data into various software tools, prolonging learning curves and slowing down productivity. Moreover, transferring data between tools introduces opportunities for misinterpretation and may jeopardize modeling outcomes.

3. Validation Challenges

Each tool necessitates independent validation, consuming valuable time and resources. Modelers must ensure that each PBPK platform yields consistent results, necessitating exhaustive validation efforts when models are transferred to a new platform. This additional step not only delays development timelines but may also introduce uncertainties regarding model reliability and accuracy.

The Solution: One Platform for all PBPK Simulations

1. Seamless Integration

A unified PBPK modeling platform harmonizes the development workflow, providing a cohesive environment from model inception to regulatory submission. By bringing together all the functionality that you will need within one PBPK platform, the data integration becomes effortless so you can focus more on the design of the model and enhancing your overall efficiencies.

2. Continuity and Consistency

Using a single PBPK platform throughout the drug development process ensures workflow continuity and develops consistency throughout the modeling process. Modelers operating within a familiar user interface can quickly move through tasks and obtain further understanding of the problem they are looking to solve. Furthermore, data integrity is preserved and model structures are retained, mitigating the risk of errors and the need to use simpler modeling approaches when you move between different PBPK platforms.

3. Streamlined Validation

With a unified platform, validation efforts are consolidated, expediting the validation process while enhancing confidence in model accuracy and reliability. Modelers validate the PBPK platform once, leveraging its capabilities across all development stages. This approach not only accelerates development timelines but also ensures regulatory confidence in the robustness of modeling outcomes.

How to Choose an All-in-One PBPK Platform

The benefits of using a single PBPK platform are clear, but that doesn’t mean all such platforms are equal. Even if they appear to check the boxes in the areas you require, it’s critical to dig below the surface to ensure the software you select offers reliable predictions and actionable data.

When choosing a PBPK platform to support the whole drug development process you need to ensure that it includes all the elements to support your modeling and simulation team.

As you research and talk to vendors, ask…

  • Does the platform include both animal and human populations? If so, what animal species are included? Are there multiple human populations, ranging in age, health and/or ethnicity?
  • Does it offer minimal and full absorption modeling capabilities?
  • How easy or difficult is asset management?
  • Within the platform, can you generate data visualizations and accessible data for submission-ready reports?
  • Is it supported and maintained to maximize new science/functionality improvements while minimizing security risks?
  • Has there been significant published evidence of the platform application at each stage of development across different drug modalities, starting from discovery and going through post-approval?
  • Are the equations underlying the PBPK predictions the platform makes available for review?
  • Does the platform undergo systemic quality control during development to ensure results are reproducible?

Conclusion

The adoption of a single PBPK modeling platform for the entire drug development process offers operational efficiencies, improved data consistency, time savings, and more. Choosing the right platform, however, is critical to realizing those benefits.

If you’d like to see how GastroPlus® X can help you optimize your drug development process, schedule a demo and we’ll help you get started.