Physiologically Based Pharmacokinetic Modeling of Biologic Case Studies in Monkeys and Humans Reveals the Necessity of an Additional Clearance Term.

ABSTRACT: Background/Objectives: Physiologically based pharmacokinetic (PBPK) modeling is an important tool in biologic drug development. However, a standardized modeling strategy is currently missing. A cross-industry collaboration developed PBPK models for seven case studies, including monoclonal antibodies, antibody-drug conjugates, and bispecific T-cell engagers, to identify key parameters and establish a workflow to simulate biologic drugs in monkeys and in humans. Methods: PBPK models were developed in the monkey with limited data, including the molecular weight, the binding affinity to FcRn, and the additional systemic clearance of IgG, which is 20% of the total clearance. The binding affinity was only available for human FcRn and corrected for the known species-dependent differ

SUBMITTER: Stader F 

PROVIDER: S-EPMC12115253 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature