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Regulatory agencies currently recommend itraconazole ( ITZ ) as a strong cytochrome P450 3A ( CYP 3A) 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 a mechanistic ITZ physiologically‐based pharmacokinetic model and provide recommendations for optimal  DDI  study design based on model simulations. To support model development and verification,  in vitro  and clinical  PK  data for  ITZ  and its metabolites were collected from  WG  member companies. The model predictions of  ITZ DDI s with seven different  CYP 3A substrates were within the guest criteria for 92% of  area under the concentration‐time curve  ratios and 95% of maximum plasma concentration ratios, thus verifying the model for  DDI  predictions. The verified model was used to simulate various clinical  DDI  study scenarios considering formulation, duration of dosing, dose regimen, and food status to recommend the optimal design for maximal inhibitory effect by  ITZ .

cpt: pharmacometrics and systems pharmacology

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