PBBM Report Template: Considerations for Improved Quality in View of Regulatory Submissions

Sponsored by the Regulatory Advisory Committee

Pharmaceutical innovators and generic companies employ Physiologically Based Biopharmaceutics Models (PBBMs) to inform drug product development and may be able to waive clinical pharmacokinetic studies for changes occurring both before and after product approval. The 2023 M-CERSI workshop titled “PBBM Best Practices for Drug Product Quality: Regulatory and Industry Perspectives” recognized that a standardized PBBM report template could benefit both industry stakeholders and regulatory bodies. This webinar will discuss the PBBM report template, which summarizes a set of expectations and proposes a structure for presenting input data, modeling plan, context of the model, model parameters, and clinical data on which the model was developed and validated to minimize the number of PBBM rejections in the future. Efforts have been made to align the framework presented in the PBBM report template with the overarching ICH M15 Guideline on Model Informed Drug Development (MIDD).

For further information about the PBBM report template, please refer to the publication Arora et al. Development of a Physiologically Based Biopharmaceutics Model (PBBM) Report Template: Considerations for Improved Quality in View of Regulatory Submissions. Molecular Pharmaceutics (submission in progress)