A generic framework for the physiologically‐based pharmacokinetic platform qualification of PK‐Sim and its application to predicting cytochrome P450 3A4-mediated drug-drug interactions

• Main Authors: Sebastian Frechen (Author), Juri Solodenko (Author), Thomas Wendl (Author), André Dallmann (Author), Ibrahim Ince (Author), Thorsten Lehr (Author), Jörg Lippert (Author), Rolf Burghaus (Author)
• Format: Book
• Published: Wiley, 2021-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract The success of applications of physiologically‐based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a particular intended application purp...