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Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug.
Vieira ML, Kirby B, Ragueneau-Majlessi I, Galetin A, Chien JY, Einolf HJ, Fahmi OA, Fischer V, Fretland A, Grime K, Hall SD, Higgs R, Plowchalk D, Riley R, Seibert E, Skordos K, Snoeys J, Venkatakrishnan K, Waterhouse T, Obach RS, Berglund EG, Zhang L, Zhao P, Reynolds KS, Huang SM. Vieira ML, et al. Among authors: einolf hj. Clin Pharmacol Ther. 2014 Feb;95(2):189-98. doi: 10.1038/clpt.2013.187. Epub 2013 Sep 18. Clin Pharmacol Ther. 2014. PMID: 24048277
The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the pharmaceutical research and manufacturers of America.
Grimm SW, Einolf HJ, Hall SD, He K, Lim HK, Ling KH, Lu C, Nomeir AA, Seibert E, Skordos KW, Tonn GR, Van Horn R, Wang RW, Wong YN, Yang TJ, Obach RS. Grimm SW, et al. Among authors: einolf hj. Drug Metab Dispos. 2009 Jul;37(7):1355-70. doi: 10.1124/dmd.109.026716. Epub 2009 Apr 9. Drug Metab Dispos. 2009. PMID: 19359406
Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.
Chen Y, Cabalu TD, Callegari E, Einolf H, Liu L, Parrott N, Peters SA, Schuck E, Sharma P, Tracey H, Upreti VV, Zheng M, Zhu AZX, Hall SD. Chen Y, et al. CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):685-695. doi: 10.1002/psp4.12449. Epub 2019 Aug 7. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31215774 Free PMC article.
Efflux transporters and their clinical relevance.
Fischer V, Einolf HJ, Cohen D. Fischer V, et al. Among authors: einolf hj. Mini Rev Med Chem. 2005 Feb;5(2):183-95. doi: 10.2174/1389557053402756. Mini Rev Med Chem. 2005. PMID: 15720288 Review.
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, Peters SA, Reddy VP, Zheng M, de Zwart L, Beneton M, Bouzom F, Chen J, Chen Y, Cleary Y, Collins C, Dickinson GL, Djebli N, Einolf HJ, Gardner I, Huth F, Kazmi F, Khalil F, Lin J, Odinecs A, Patel C, Rong H, Schuck E, Sharma P, Wu SP, Xu Y, Yamazaki S, Yoshida K, Rowland M. Shebley M, et al. Among authors: einolf hj. Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Clin Pharmacol Ther. 2018. PMID: 29315504 Free PMC article. Review.
Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control.
Hariparsad N, Ramsden D, Palamanda J, Dekeyser JG, Fahmi OA, Kenny JR, Einolf H, Mohutsky M, Pardon M, Siu YA, Chen L, Sinz M, Jones B, Walsky R, Dallas S, Balani SK, Zhang G, Buckley D, Tweedie D. Hariparsad N, et al. Drug Metab Dispos. 2017 Oct;45(10):1049-1059. doi: 10.1124/dmd.116.074567. Epub 2017 Jun 23. Drug Metab Dispos. 2017. PMID: 28646080
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