Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically‐Based Pharmacokinetic Model

• Main Authors: Yuan Chen (Author), Tamara D. Cabalu (Author), Ernesto Callegari (Author), Heidi Einolf (Author), Lichuan Liu (Author), Neil Parrott (Author), Sheila Annie Peters (Author), Edgar Schuck (Author), Pradeep Sharma (Author), Helen Tracey (Author), Vijay V. Upreti (Author), Ming Zheng (Author), Andy Z.X. Zhu (Author), Stephen D. Hall (Author)
• Format: Book
• Published: Wiley, 2019-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Regulatory agencies currently recommend itraconazole (ITZ) as a strong cytochrome P450 3A (CYP3A) inhibitor for clinical drug-drug interaction (DDI) studies. This work by an International Consortium for Innovation and Quality in Pharmaceutical Development working group (WG) is to develop and verify...