Recommendations for the Design of Clinical Drug–Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically‐Based Pharmacokinetic Model-Reference-Cited by-同舟云学术

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

Published:2019-08-07 Issue:9 Volume:8 Page:685-695
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Chen Yuan¹,Cabalu Tamara D.²,Callegari Ernesto³,Einolf Heidi⁴,Liu Lichuan⁵,Parrott Neil⁶,Peters Sheila Annie⁷^ORCID,Schuck Edgar⁸,Sharma Pradeep⁹,Tracey Helen¹⁰,Upreti Vijay V.¹¹,Zheng Ming¹²,Zhu Andy Z.X.¹³,Hall Stephen D.¹⁴

Affiliation:

1. Department of Drug Metabolism and Pharmacokinetics Genentech Inc., a member of the Roche Group South San Francisco California USA

2. Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism Merck & Co., Inc. Kenilworth New Jersey USA

3. Pharmacokinetics, Dynamics and Metabolism Pfizer Inc. Groton Connecticut USA

4. Modeling & Simulation, PK Sciences Novartis Institutes for Biomedical Research East Hanover New Jersey USA

5. Genentech Inc., a member of the Roche Group South San Francisco California USA

6. Pharmaceutical Sciences, Pharmaceutical Research and Early Development Roche Innovation Centre, Basel F. Hoffmann‐La Roche Ltd. Basel Switzerland

7. Translational Quantitative Pharmacology Merck KGaA Darmstadt Germany

8. Modeling & Simulation, Clinical Pharmacology Science/Medicine Development Center (MDC) Eisai Inc. Woodcliff Lake New Jersey USA

9. Mechanistic Safety and ADME Sciences Drug Safety and Metabolism Innovative Medicines (IMED) Biotech Unit AstraZeneca R&D Cambridge UK

10. Department of Mechanistic Safety and Disposition GlaxoSmithKline Hertfordshire UK

11. Clinical Pharmacology Modeling and Simulation Amgen Inc. South San Francisco California USA

12. Clinical Pharmacology and Pharmacometrics Bristol‐Myers Squibb Company Princeton New Jersey USA

13. Department of Drug Metabolism and Pharmacokinetics Takeda Pharmaceuticals International Co. Cambridge Massachusetts USA

14. Lilly Research Laboratories Eli Lilly and Company Indianapolis Indiana USA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12449

Reference42 articles.

1. European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole. Benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections. EMA/458028/2013. (2013). .

2. FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems. UCM 362444. (2013). UCM. .

3. Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies

4. Development of a Physiologically Based Pharmacokinetic Model for Itraconazole Pharmacokinetics and Drug–Drug Interaction Prediction

5. Itraconazole and Clarithromycin as Ketoconazole Alternatives for Clinical CYP3A Inhibition Studies

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