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Items: 29


Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance.

Kenny JR, Ramsden D, Buckley DB, Dallas S, Fung C, Mohutsky M, Einolf HJ, Chen L, Dekeyser JG, Fitzgerald M, Goosen TC, Siu YA, Walsky RL, Zhang G, Tweedie D, Hariparsad N.

Drug Metab Dispos. 2018 Sep;46(9):1285-1303. doi: 10.1124/dmd.118.081927. Epub 2018 Jun 29.


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.

Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Review.


Simultaneous Physiologically Based Pharmacokinetic (PBPK) Modeling of Parent and Active Metabolites to Investigate Complex CYP3A4 Drug-Drug Interaction Potential: A Case Example of Midostaurin.

Gu H, Dutreix C, Rebello S, Ouatas T, Wang L, Chun DY, Einolf HJ, He H.

Drug Metab Dispos. 2018 Feb;46(2):109-121. doi: 10.1124/dmd.117.078006. Epub 2017 Nov 8.


Evaluation of Clinical Drug Interaction Potential of Clofazimine Using Static and Dynamic Modeling Approaches.

Sangana R, Gu H, Chun DY, Einolf HJ.

Drug Metab Dispos. 2018 Jan;46(1):26-32. doi: 10.1124/dmd.117.077834. Epub 2017 Oct 16.


Physiologically Based Pharmacokinetic Model Predictions of Panobinostat (LBH589) as a Victim and Perpetrator of Drug-Drug Interactions.

Einolf HJ, Lin W, Won CS, Wang L, Gu H, Chun DY, He H, Mangold JB.

Drug Metab Dispos. 2017 Dec;45(12):1304-1316. doi: 10.1124/dmd.117.076851. Epub 2017 Sep 14.


Drug Interaction Potential of Osilodrostat (LCI699) Based on Its Effect on the Pharmacokinetics of Probe Drugs of Cytochrome P450 Enzymes in Healthy Adults.

Armani S, Ting L, Sauter N, Darstein C, Tripathi AP, Wang L, Zhu B, Gu H, Chun DY, Einolf HJ, Kulkarni S.

Clin Drug Investig. 2017 May;37(5):465-472. doi: 10.1007/s40261-017-0497-0.


A Physiologically-Based Pharmacokinetic Modeling Approach To Predict Drug-Drug Interactions of Sonidegib (LDE225) with Perpetrators of CYP3A in Cancer Patients.

Einolf HJ, Zhou J, Won C, Wang L, Rebello S.

Drug Metab Dispos. 2017 Apr;45(4):361-374. doi: 10.1124/dmd.116.073585. Epub 2017 Jan 25.


Pradigastat disposition in humans: in vivo and in vitro investigations.

Upthagrove A, Chen J, Meyers CD, Kulmatycki K, Bretz A, Wang L, Peng L, Palamar S, Lin M, Majumdar T, Tran P, Einolf HJ.

Xenobiotica. 2017 Dec;47(12):1077-1089. doi: 10.1080/00498254.2016.1263405. Epub 2016 Dec 12.


Clinical disposition, metabolism and in vitro drug-drug interaction properties of omadacycline.

Flarakos J, Du Y, Gu H, Wang L, Einolf HJ, Chun DY, Zhu B, Alexander N, Natrillo A, Hanna I, Ting L, Zhou W, Dole K, Sun H, Kovacs SJ, Stein DS, Tanaka SK, Villano S, Mangold JB.

Xenobiotica. 2017 Aug;47(8):682-696. doi: 10.1080/00498254.2016.1213465. Epub 2016 Aug 8.


Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective.

Fahmi OA, Shebley M, Palamanda J, Sinz MW, Ramsden D, Einolf HJ, Chen L, Wang H.

Drug Metab Dispos. 2016 Oct;44(10):1720-30. doi: 10.1124/dmd.116.071076. Epub 2016 Jul 15.


Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions-an Industry Perspective.

Bohnert T, Patel A, Templeton I, Chen Y, Lu C, Lai G, Leung L, Tse S, Einolf HJ, Wang YH, Sinz M, Stearns R, Walsky R, Geng W, Sudsakorn S, Moore D, He L, Wahlstrom J, Keirns J, Narayanan R, Lang D, Yang X; International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Victim Drug-Drug Interactions Working Group.

Drug Metab Dispos. 2016 Aug;44(8):1399-423. doi: 10.1124/dmd.115.069096. Epub 2016 Apr 6. Review.


Disposition and metabolism of [(14)C] Sacubitril/Valsartan (formerly LCZ696) an angiotensin receptor neprilysin inhibitor, in healthy subjects.

Flarakos J, Du Y, Bedman T, Al-Share Q, Jordaan P, Chandra P, Albrecht D, Wang L, Gu H, Einolf HJ, Huskey SE, Mangold JB.

Xenobiotica. 2016 Nov;46(11):986-1000. doi: 10.3109/00498254.2015.1014944. Epub 2016 Mar 2.


Identification of Three Novel Ring Expansion Metabolites of KAE609, a New Spiroindolone Agent for the Treatment of Malaria, in Rats, Dogs, and Humans.

Huskey SE, Zhu CQ, Lin MM, Forseth RR, Gu H, Simon O, Eggimann FK, Kittelmann M, Luneau A, Vargas A, Li H, Wang L, Einolf HJ, Zhang J, Favara S, He H, Mangold JB.

Drug Metab Dispos. 2016 May;44(5):653-64. doi: 10.1124/dmd.115.069112. Epub 2016 Feb 26.


Evaluation of calibration curve-based approaches to predict clinical inducers and noninducers of CYP3A4 with plated human hepatocytes.

Zhang JG, Ho T, Callendrello AL, Clark RJ, Santone EA, Kinsman S, Xiao D, Fox LG, Einolf HJ, Stresser DM.

Drug Metab Dispos. 2014 Sep;42(9):1379-91. doi: 10.1124/dmd.114.058602. Epub 2014 Jun 12.


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.

Clin Pharmacol Ther. 2014 Feb;95(2):189-98. doi: 10.1038/clpt.2013.187. Epub 2013 Sep 18.


Evaluation of various static and dynamic modeling methods to predict clinical CYP3A induction using in vitro CYP3A4 mRNA induction data.

Einolf HJ, Chen L, Fahmi OA, Gibson CR, Obach RS, Shebley M, Silva J, Sinz MW, Unadkat JD, Zhang L, Zhao P.

Clin Pharmacol Ther. 2014 Feb;95(2):179-88. doi: 10.1038/clpt.2013.170. Epub 2013 Aug 29.


Assessment of cytochrome p450 enzyme inhibition and inactivation in drug discovery and development.

Nettleton DO, Einolf HJ.

Curr Top Med Chem. 2011;11(4):382-403. Review.


Cytochrome P450 1A2 detoxicates aristolochic acid in the mouse.

Rosenquist TA, Einolf HJ, Dickman KG, Wang L, Smith A, Grollman AP.

Drug Metab Dispos. 2010 May;38(5):761-8. doi: 10.1124/dmd.110.032201. Epub 2010 Feb 17.


In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america perspective.

Chu V, Einolf HJ, Evers R, Kumar G, Moore D, Ripp S, Silva J, Sinha V, Sinz M, Skerjanec A.

Drug Metab Dispos. 2009 Jul;37(7):1339-54. doi: 10.1124/dmd.109.027029. Epub 2009 Apr 23.


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.

Drug Metab Dispos. 2009 Jul;37(7):1355-70. doi: 10.1124/dmd.109.026716. Epub 2009 Apr 9.


Comparison of different approaches to predict metabolic drug-drug interactions.

Einolf HJ.

Xenobiotica. 2007 Oct-Nov;37(10-11):1257-94.


Efflux transporters and their clinical relevance.

Fischer V, Einolf HJ, Cohen D.

Mini Rev Med Chem. 2005 Feb;5(2):183-95. Review.


The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective.

Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach RS, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism/Clinical Pharmacology Technical Working Group; FDA Center for Drug Evaluation and Research (CDER).

Drug Metab Dispos. 2003 Jul;31(7):815-32.


The conduct of in vitro and in vivo drug-drug interaction studies: a PhRMA perspective.

Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, Kumar G, McLeod J, Obach SR, Roberts S, Roe A, Shah A, Snikeris F, Sullivan JT, Tweedie D, Vega JM, Walsh J, Wrighton SA; Pharmaceutical Research and Manufacturers of America Drug Metabolism/Clinical Pharmacology Technical Working Groups.

J Clin Pharmacol. 2003 May;43(5):443-69. Review.


Kinetic analysis of nucleotide incorporation by mammalian DNA polymerase delta.

Einolf HJ, Guengerich FP.

J Biol Chem. 2000 May 26;275(21):16316-22.


Role of cytochrome P450 enzyme induction in the metabolic activation of benzo[c]phenanthrene in human cell lines and mouse epidermis.

Einolf HJ, Story WT, Marcus CB, Larsen MC, Jefcoate CR, Greenlee WF, Yagi H, Jerina DM, Amin S, Park SS, Gelboin HV, Baird WM.

Chem Res Toxicol. 1997 May;10(5):609-17.


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