Clinical Pharmacology – Chemical
This session will provide a description for the use of physiologically based pharmacokinetic modeling (PBPK) in drug development and regulatory submissions. The session will also cover the biopharmaceutical and drug interaction uses of PBPK modeling. A special focus will be given to the use of PBPK to inform pediatric clinical study design. The methods of assessment of PBPK models will be discussed. A regulatory guidance on the qualification and reporting of the PBPK models from European Medicines Agency (EMA) perspective will be provided.