PBPK Modeling and Simulation for Regulatory Decision Making: Impact on US Prescribing Information

A presentation on the paper ‘Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharmacology’ by 4th November 2021, Xinyuan (Susie) Zhang and Yuching Yang, US FDA, Silver Spring, MD, USA

• Provide the up-to-date statistics on the PBPK submissions to the Office of Clinical Pharmacology (OCP)
• Introduce the roles and responsibilities of PBPK reviewers
• Discuss the regulatory scientific considerations of PBPK analysis at different stages of submissions
• Present case examples to illustrate the scientific considerations of PBPK analysis in different areas of applications

Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.