Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions.

ABSTRACT: Pharmaceutical innovators and generic companies use Physiologically Based Biopharmaceutics Models (PBBMs) to guide drug product development and potentially waive clinical pharmacokinetic studies for both pre- and postapproval changes. This modeling approach can assist with biopharmaceutics risk assessment and the establishment of patient centric, clinically relevant drug product specifications. However, the variability of possible model strategies and the existence of gaps in scientific knowledge associated with the lack of standardized regulatory expectations for model parametrization, data requirements for model development, and criteria for fit-for-purpose model validation leads to varied acceptance rates and frequent requests for additional information and deficiencies in PBBM submissi

SUBMITTER: Arora S 

PROVIDER: S-EPMC12135060 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature