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In vitro-in vivo extrapolation and hepatic clearance dependent underprediction.

Bowman CM, Benet LZ.

J Pharm Sci. 2019 Feb 25. pii: S0022-3549(19)30094-2. doi: 10.1016/j.xphs.2019.02.009. [Epub ahead of print]


Characterization of fasiglifam-related liver toxicity in dogs.

Kogame A, Moriya Y, Mori I, Pan L, Morohashi A, Ebihara T, Fukui H, Tagawa Y, Benet LZ.

Drug Metab Dispos. 2019 Feb 14. pii: dmd.118.084889. doi: 10.1124/dmd.118.084889. [Epub ahead of print]


The Presence of a Transporter-Induced Protein Binding Shift: A New Explanation for Protein-Facilitated Uptake and Improvement for In Vitro-In Vivo Extrapolation.

Bowman CM, Okochi H, Benet LZ.

Drug Metab Dispos. 2019 Apr;47(4):358-363. doi: 10.1124/dmd.118.085779. Epub 2019 Jan 23.


Batch-to-Batch and Within-Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?

Benet LZ, Jayachandran P, Carroll KJ, Burmeister Getz E.

Clin Pharmacol Ther. 2019 Feb;105(2):326-328. doi: 10.1002/cpt.1294. Epub 2019 Jan 16. No abstract available.


Evaluating Within-Subject Variability for Narrow Therapeutic Index Drugs.

Jayachandran P, Okochi H, Frassetto LA, Park W, Fang L, Zhao L, Benet LZ.

Clin Pharmacol Ther. 2019 Feb;105(2):411-416. doi: 10.1002/cpt.1293. Epub 2019 Jan 16.


TPT sulfonate, a single, oral dose schistosomicidal prodrug: In vivo efficacy, disposition and metabolic profiling.

Wolfe AR, Neitz RJ, Burlingame M, Suzuki BM, Lim KC, Scheideler M, Nelson DL, Benet LZ, Caffrey CR.

Int J Parasitol Drugs Drug Resist. 2018 Dec;8(3):571-586. doi: 10.1016/j.ijpddr.2018.10.004. Epub 2018 Nov 20.


Ascorbic acid metabolites are involved in intraocular pressure control in the general population.

Hysi PG, Khawaja AP, Menni C, Tamraz B, Wareham N, Khaw KT, Foster PJ, Benet LZ, Spector TD, Hammond CJ.

Redox Biol. 2019 Jan;20:349-353. doi: 10.1016/j.redox.2018.10.004. Epub 2018 Oct 13.


The Extended Clearance Concept Following Oral and Intravenous Dosing: Theory and Critical Analyses.

Benet LZ, Bowman CM, Liu S, Sodhi JK.

Pharm Res. 2018 Oct 22;35(12):242. doi: 10.1007/s11095-018-2524-0.


An examination of protein binding and protein-facilitated uptake relating to in vitro-in vivo extrapolation.

Bowman CM, Benet LZ.

Eur J Pharm Sci. 2018 Oct 15;123:502-514. doi: 10.1016/j.ejps.2018.08.008. Epub 2018 Aug 8. Review.


Evaluation of the Relevance of DILI Predictive Hypotheses in Early Drug Development: Review of In Vitro Methodologies vs BDDCS Classification.

Chan R, Benet LZ.

Toxicol Res (Camb). 2018 May 8;7(3):358-370. doi: 10.1039/C8TX00016F. Epub 2018 Apr 18.


Predicting Pharmacokinetics/Pharmacodynamics in the Individual Patient: Separating Reality From Hype.

Benet LZ.

J Clin Pharmacol. 2018 Apr 17. doi: 10.1002/jcph.1105. [Epub ahead of print] Review.


Why Drugs Fail in Late Stages of Development: Case Study Analyses from the Last Decade and Recommendations.

Parasrampuria DA, Benet LZ, Sharma A.

AAPS J. 2018 Mar 13;20(3):46. doi: 10.1208/s12248-018-0204-y.


Development and validation of an assay to analyze atazanavir in human hair via liquid chromatography/tandem mass spectrometry.

Phung N, Kuncze K, Okochi H, Louie A, Benet LZ, Ofokotun I, Haas DW, Currier JS, Chawana TD, Sheth AN, Bacchetti P, Gandhi M, Horng H.

Rapid Commun Mass Spectrom. 2018 Mar 15;32(5):431-441. doi: 10.1002/rcm.8058.


Local delivery of hormonal therapy with silastic tubing for prevention and treatment of breast cancer.

Park J, Thomas S, Zhong AY, Wolfe AR, Krings G, Terranova-Barberio M, Pawlowska N, Benet LZ, Munster PN.

Sci Rep. 2018 Jan 8;8(1):92. doi: 10.1038/s41598-017-18436-1.


Measures of BSEP Inhibition In Vitro Are Not Useful Predictors of DILI.

Chan R, Benet LZ.

Toxicol Sci. 2018 Apr 1;162(2):499-508. doi: 10.1093/toxsci/kfx284.


Comparison of Measures of Adherence to Human Immunodeficiency Virus Preexposure Prophylaxis Among Adolescent and Young Men Who Have Sex With Men in the United States.

Koss CA, Hosek SG, Bacchetti P, Anderson PL, Liu AY, Horng H, Benet LZ, Kuncze K, Louie A, Saberi P, Wilson CM, Gandhi M.

Clin Infect Dis. 2018 Jan 6;66(2):213-219. doi: 10.1093/cid/cix755.


The Universally Unrecognized Assumption in Predicting Drug Clearance and Organ Extraction Ratio.

Benet LZ, Liu S, Wolfe AR.

Clin Pharmacol Ther. 2018 Mar;103(3):521-525. doi: 10.1002/cpt.802. Epub 2017 Sep 6.


Commentary on: "Influence of OATP1B1 Function on the Disposition of Sorafenib-β-D-Glucuronide".

Morrissey KM, Benet LZ, Ware JA.

Clin Transl Sci. 2017 Jul;10(4):240-241. doi: 10.1111/cts.12476. Epub 2017 Jun 29. No abstract available.


Understanding the Potential Interethnic Difference in Rosuvastatin Pharmacokinetics.

Benet LZ, Wu HF.

J Pharm Sci. 2017 Sep;106(9):2231-2233. doi: 10.1016/j.xphs.2017.05.008. Epub 2017 May 11.


Cellular Uptake of Levocetirizine by Organic Anion Transporter 4.

Noguchi S, Nishimura T, Mukaida S, Benet LZ, Nakashima E, Tomi M.

J Pharm Sci. 2017 Sep;106(9):2895-2898. doi: 10.1016/j.xphs.2017.03.026. Epub 2017 Apr 4.


Rosuvastatin Pharmacokinetics in Asian and White Subjects Wild Type for Both OATP1B1 and BCRP Under Control and Inhibited Conditions.

Wu HF, Hristeva N, Chang J, Liang X, Li R, Frassetto L, Benet LZ.

J Pharm Sci. 2017 Sep;106(9):2751-2757. doi: 10.1016/j.xphs.2017.03.027. Epub 2017 Apr 3.


Classification of natural products as sources of drugs according to the biopharmaceutics drug disposition classification system (BDDCS).

Li J, Larregieu CA, Benet LZ.

Chin J Nat Med. 2016 Dec;14(12):888-897. doi: 10.1016/S1875-5364(17)30013-4. Review.


Evaluation of DILI Predictive Hypotheses in Early Drug Development.

Chan R, Benet LZ.

Chem Res Toxicol. 2017 Apr 17;30(4):1017-1029. doi: 10.1021/acs.chemrestox.7b00025. Epub 2017 Mar 15.


Differences in Cumulative Exposure and Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as Determined via Hair Concentrations.

Koss CA, Bacchetti P, Hillier SL, Livant E, Horng H, Mgodi N, Mirembe BG, Gomez Feliciano K, Horn S, Liu AY, Glidden DV, Grant RM, Benet LZ, Louie A, van der Straten A, Chirenje ZM, Marrazzo JM, Gandhi M.

AIDS Res Hum Retroviruses. 2017 Aug;33(8):778-783. doi: 10.1089/aid.2016.0202. Epub 2017 Mar 2.


Meal Effects Confound Attempts to Counteract Rabeprazole-Induced Hypochlorhydria Decreases in Atazanavir Absorption.

Faber KP, Wu HF, Yago MR, Xu X, Kadiyala P, Frassetto LA, Benet LZ.

Pharm Res. 2017 Mar;34(3):619-628. doi: 10.1007/s11095-016-2090-2. Epub 2016 Dec 27.


Association of age, baseline kidney function, and medication exposure with declines in creatinine clearance on pre-exposure prophylaxis: an observational cohort study.

Gandhi M, Glidden DV, Mayer K, Schechter M, Buchbinder S, Grinsztejn B, Hosek S, Casapia M, Guanira J, Bekker LG, Louie A, Horng H, Benet LZ, Liu A, Grant RM.

Lancet HIV. 2016 Nov;3(11):e521-e528. doi: 10.1016/S2352-3018(16)30153-9. Epub 2016 Aug 31.


Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial.

Burmeister Getz E, Carroll KJ, Mielke J, Benet LZ, Jones B.

Clin Pharmacol Ther. 2017 Mar;101(3):331-340. doi: 10.1002/cpt.535. Epub 2016 Nov 26.


Hepatic Clearance Predictions from In Vitro-In Vivo Extrapolation and the Biopharmaceutics Drug Disposition Classification System.

Bowman CM, Benet LZ.

Drug Metab Dispos. 2016 Nov;44(11):1731-1735. Epub 2016 Aug 12.


2016 Remington Honor Medal Address: Science for the profession.

Benet LZ.

J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):365-8. doi: 10.1016/j.japh.2016.06.008. No abstract available.


BDDCS, the Rule of 5 and drugability.

Benet LZ, Hosey CM, Ursu O, Oprea TI.

Adv Drug Deliv Rev. 2016 Jun 1;101:89-98. doi: 10.1016/j.addr.2016.05.007. Epub 2016 May 13. Review.


Isoniazid hair concentrations in children with tuberculosis: a proof of concept study.

Mave V, Chandanwale A, Kinikar A, Khadse S, Kagal A, Gupte N, Suryavanshi N, Nimkar S, Koli H, Khwaja S, Bharadwaj R, Joshi S, Horng H, Benet LZ, Ramachandran G, Dooley KE, Gupta A, Gandhi M.

Int J Tuberc Lung Dis. 2016 Jun;20(6):844-7. doi: 10.5588/ijtld.15.0882.


Batch-to-batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial.

Burmeister Getz E, Carroll KJ, Jones B, Benet LZ.

Clin Pharmacol Ther. 2016 Sep;100(3):223-31. doi: 10.1002/cpt.373. Epub 2016 Apr 28.


BDDCS Predictions, Self-Correcting Aspects of BDDCS Assignments, BDDCS Assignment Corrections, and Classification for more than 175 Additional Drugs.

Hosey CM, Chan R, Benet LZ.

AAPS J. 2016 Jan;18(1):251-60. doi: 10.1208/s12248-015-9845-2. Epub 2015 Nov 20. Review.


Reliability of In Vitro and In Vivo Methods for Predicting the Effect of P-Glycoprotein on the Delivery of Antidepressants to the Brain.

Zheng Y, Chen X, Benet LZ.

Clin Pharmacokinet. 2016 Feb;55(2):143-67. doi: 10.1007/s40262-015-0310-2. Review.


Few Drugs Display Flip-Flop Pharmacokinetics and These Are Primarily Associated with Classes 3 and 4 of the BDDCS.

Garrison KL, Sahin S, Benet LZ.

J Pharm Sci. 2015 Sep;104(9):3229-35. doi: 10.1002/jps.24505. Epub 2015 May 25.


Predicting the extent of metabolism using in vitro permeability rate measurements and in silico permeability rate predictions.

Hosey CM, Benet LZ.

Mol Pharm. 2015 May 4;12(5):1456-66. doi: 10.1021/mp500783g. Epub 2015 Apr 23.


A phase I study of targeted, dose-escalated intravenous busulfan in combination with etoposide as myeloablative therapy for autologous stem cell transplantation in acute myeloid leukemia.

Mannis GN, Andreadis C, Logan AC, Damon LE, Benet LZ, Ai WZ, Gaensler KM, Kaplan LD, Koplowicz YB, Linker CA, Olin RL, Sayre PH, Smith CC, Sudhindra A, Venstrom JM, Wolf JL, Martin TG 3rd.

Clin Lymphoma Myeloma Leuk. 2015 Jun;15(6):377-83. doi: 10.1016/j.clml.2015.02.016. Epub 2015 Feb 14.


pH Dependent but not P-gp Dependent Bidirectional Transport Study of S-propranolol: The Importance of Passive Diffusion.

Zheng Y, Benet LZ, Okochi H, Chen X.

Pharm Res. 2015 Aug;32(8):2516-26. doi: 10.1007/s11095-015-1640-3. Epub 2015 Feb 19.


Inclusion of placebos and blinding for ascending dose first-in-human studies and other underpowered phase 1 studies has not been justified and on balance is not useful.

Parasrampuria DA, Benet LZ.

Basic Clin Pharmacol Toxicol. 2015 Jul;117(1):44-51. doi: 10.1111/bcpt.12352. Epub 2014 Dec 23. Review.


The use of betaine HCl to enhance dasatinib absorption in healthy volunteers with rabeprazole-induced hypochlorhydria.

Yago MR, Frymoyer A, Benet LZ, Smelick GS, Frassetto LA, Ding X, Dean B, Salphati L, Budha N, Jin JY, Dresser MJ, Ware JA.

AAPS J. 2014 Nov;16(6):1358-65. doi: 10.1208/s12248-014-9673-9. Epub 2014 Oct 2.


Predicting when biliary excretion of parent drug is a major route of elimination in humans.

Hosey CM, Broccatelli F, Benet LZ.

AAPS J. 2014 Sep;16(5):1085-96. doi: 10.1208/s12248-014-9636-1. Epub 2014 Jul 9.


Mouse liver repopulation with hepatocytes generated from human fibroblasts.

Zhu S, Rezvani M, Harbell J, Mattis AN, Wolfe AR, Benet LZ, Willenbring H, Ding S.

Nature. 2014 Apr 3;508(7494):93-7. doi: 10.1038/nature13020. Epub 2014 Feb 23.


Best single time point correlations with AUC for cyclosporine and tacrolimus in HIV-infected kidney and liver transplant recipients.

Frassetto LA, Tan-Tam CC, Barin B, Browne M, Wolfe AR, Stock PG, Roland M, Benet LZ.

Transplantation. 2014 Mar 27;97(6):702-7. doi: 10.1097/01.TP.0000441097.30094.31.


Effect of P-glycoprotein on the rat intestinal permeability and metabolism of the BDDCS class 1 drug verapamil.

Estudante M, Maya M, Morais JG, Soveral G, Benet LZ.

Mol Pharm. 2013 Nov 4;10(11):4038-45. doi: 10.1021/mp400381p. Epub 2013 Sep 27.


Prevalence of acid-reducing agents (ARA) in cancer populations and ARA drug-drug interaction potential for molecular targeted agents in clinical development.

Smelick GS, Heffron TP, Chu L, Dean B, West DA, Duvall SL, Lum BL, Budha N, Holden SN, Benet LZ, Frymoyer A, Dresser MJ, Ware JA.

Mol Pharm. 2013 Nov 4;10(11):4055-62. doi: 10.1021/mp400403s. Epub 2013 Oct 24.


Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria.

Yago MR, Frymoyer AR, Smelick GS, Frassetto LA, Budha NR, Dresser MJ, Ware JA, Benet LZ.

Mol Pharm. 2013 Nov 4;10(11):4032-7. doi: 10.1021/mp4003738. Epub 2013 Sep 10.


The nonenzymatic reactivity of the acyl-linked metabolites of mefenamic acid toward amino and thiol functional group bionucleophiles.

Horng H, Benet LZ.

Drug Metab Dispos. 2013 Nov;41(11):1923-33. doi: 10.1124/dmd.113.053223. Epub 2013 Aug 23.

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