Will harmonization in guidance lead to consistency in assessment and regulatory decisions, with a focus on PBPK modeling in new drug approvals (NDAs) and marketing authorization applications (MAAs)?

Description of session (include background & scientific importance): PBPK modeling has become an invaluable tool in drug development, and its application in regulatory submissions has evolved significantly over time. Regulatory agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency) have published guidance on the use of PBPK modeling to support drug development and regulatory decisions.

Upon examining PBPK assessments published by these regulators, we found that conclusions regarding model adequacy may vary between agencies, given the same submission package was reviewed. Recently, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released two key guidelines: M12 on Drug Interaction Studies and M15 on General Principles for Model-Informed Drug Development.

Will these guidelines lead to more consistent conclusions in PBPK model assessments across regulatory agencies? In this talk, we will compare the similarities and differences among existing PBPK guidelines, explore several PBPK assessment examples from new drug approvals (NDAs) and marketing authorization applications (MAAs), and offer insights into the processes that could help harmonize assessment approaches and regulatory decisions.