Applications of PBPK for Drugs Approved by the US Food and Drug Administration in 2023 and 2024: A Review of Drug Label Clinical Trial Waivers

Presented at the 14th ISSX International Meeting, September 2025
Oliver Hatley, Olha Shuklinova, Anna Murphy, Roz Southall, Eman El-Khateeb, Jingjing Yu, Isabelle Ragueneau-Majlessi, and Iain Gardner

2025 ISSX Poster Presentation – PBPK in NDA Reviews

Abstract

The application of Physiologically Based Pharmacokinetic (PBPK) modelling in FDA NDAs was assessed across 2023 and 2024 approvals.