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Items: 1 to 50 of 63

1.

Midazolam Limited Sampling Strategy With a Population Pharmacokinetic Approach to Simultaneously Estimate Cytochrome P450 (CYP) 3A Constitutive, Inhibition, and Induction/Activation Conditions in Healthy Adults.

Yang J, Nikanjam M, Capparelli EV, Tsunoda SM, Greenberg HE, Penzak SR, Stoch SA, Bertino JS Jr, Nafziger AN, Ma JD.

J Clin Pharmacol. 2019 Nov;59(11):1495-1504. doi: 10.1002/jcph.1440. Epub 2019 May 3.

PMID:
31051051
2.

Midazolam Single Time Point Concentrations to Estimate Exposure and Cytochrome P450 (CYP) 3A Constitutive Activity Utilizing Limited Sampling Strategy With a Population Pharmacokinetic Approach.

Yang J, Patel M, Nikanjam M, Capparelli EV, Tsunoda SM, Greenberg HE, Penzak SR, Aubrey Stoch S, Bertino JS Jr, Nafziger AN, Ma JD.

J Clin Pharmacol. 2018 Sep;58(9):1205-1213. doi: 10.1002/jcph.1125. Epub 2018 Apr 17.

PMID:
29663428
3.

A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.

Edwards BD, B├ęgaud B, Daemen E, Dokas I, Fishbein JM, Greenberg HE, Hochberg A, Le Louet H, Lyngvig J, Mogles N, Owen K, Prendergast C, Rejzek M, Trantza S, Webb DJ, Whalen M, Whiteley S.

Br J Clin Pharmacol. 2017 Nov;83(11):2339-2342. doi: 10.1111/bcp.13353. Epub 2017 Jul 19.

4.

Comprehensive review of visual defects reported with topiramate.

Ford L, Goldberg JL, Selan F, Greenberg HE, Shi Y.

Clin Ophthalmol. 2017 May 23;11:983-992. doi: 10.2147/OPTH.S125768. eCollection 2017. Review.

5.

Structured Risk Assessment for First-in-Human Studies.

van Iersel MT, Greenberg HE, Westrick ML.

Ther Innov Regul Sci. 2017 May;51(3):288-297. doi: 10.1177/2168479017705156.

PMID:
30231711
6.

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost".

Greenberg HE, van Iersel MT, Westrick ML, Smith WB.

Ther Innov Regul Sci. 2017 May;51(3):276-284. doi: 10.1177/2168479017706404.

PMID:
30231706
7.

Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies: A Moderated Forum Session.

Steinman GL, Smith WB, Westrick ML, Greenberg HE.

Ther Innov Regul Sci. 2017 May;51(3):298-302. doi: 10.1177/2168479017705688.

PMID:
30231705
8.

Is uveitis associated with topiramate use? A cumulative review.

Goldberg JL, Lau AG, Fan B, Ford L, Greenberg HE.

Clin Ophthalmol. 2016 Aug 2;10:1467-70. doi: 10.2147/OPTH.S104847. eCollection 2016.

9.

Inhibition of prostacyclin and thromboxane biosynthesis in healthy volunteers by single and multiple doses of acetaminophen and indomethacin.

Schwartz JI, Musser BJ, Tanaka WK, Taggart WV, Mehta A, Gottesdiener KM, Greenberg HE.

Clin Pharmacol Drug Dev. 2015 Sep;4(5):337-45. doi: 10.1002/cpdd.194. Epub 2015 Jul 17.

PMID:
27137142
10.

Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.

Kramer JM, Vock D, Greenberg HE, Janning C, Szczech L, Salgo M, Gagnon S, Ellenberg S.

Ther Innov Regul Sci. 2014 Jul;48(4):413-419.

11.

Limited sampling strategy of partial area under the concentration-time curves to estimate midazolam systemic clearance for cytochrome P450 3A phenotyping.

Masters JC, Harano DM, Greenberg HE, Tsunoda SM, Jang IJ, Ma JD.

Ther Drug Monit. 2015 Feb;37(1):84-9. doi: 10.1097/FTD.0000000000000116.

12.

Evaluation of partial area under the concentration time curve to estimate midazolam apparent oral clearance for cytochrome P450 3A phenotyping.

Tai W, Gong SL, Tsunoda SM, Greenberg HE, Gorski JC, Penzak SR, Stoch SA, Ma JD.

Drug Metabol Drug Interact. 2013;28(4):217-23. doi: 10.1515/dmdi-2013-0040.

PMID:
24114901
13.

Respiratory effort-related arousals contribute to sympathetic modulation of heart rate variability.

Chandra S, Sica AL, Wang J, Lakticova V, Greenberg HE.

Sleep Breath. 2013 Dec;17(4):1193-200. doi: 10.1007/s11325-013-0823-6. Epub 2013 Feb 18.

PMID:
23417318
14.

MK-0448, a specific Kv1.5 inhibitor: safety, pharmacokinetics, and pharmacodynamic electrophysiology in experimental animal models and humans.

Pavri BB, Greenberg HE, Kraft WK, Lazarus N, Lynch JJ, Salata JJ, Bilodeau MT, Regan CP, Stump G, Fan L, Mehta A, Wagner JA, Gutstein DE, Bloomfield D.

Circ Arrhythm Electrophysiol. 2012 Dec;5(6):1193-201. doi: 10.1161/CIRCEP.111.969782. Epub 2012 Oct 11.

PMID:
23060423
15.
16.

Safety and immunogenicity of a novel Staphylococcus aureus vaccine: results from the first study of the vaccine dose range in humans.

Harro C, Betts R, Orenstein W, Kwak EJ, Greenberg HE, Onorato MT, Hartzel J, Lipka J, DiNubile MJ, Kartsonis N.

Clin Vaccine Immunol. 2010 Dec;17(12):1868-74. doi: 10.1128/CVI.00356-10. Epub 2010 Oct 13.

17.

Double-blind crossover study to assess potential differences in cytochrome P450 3A4 activity in healthy subjects receiving ondansetron plus dexamethasone, with and without aprepitant.

Stoch SA, Gargano C, Valentine J, Braun MP, Murphy MG, Fedgchin M, Majumdar A, Pequignot E, Gottesdiener KM, Petty KJ, Panebianco D, Dean D, Kraft WK, Greenberg HE.

Cancer Chemother Pharmacol. 2011 Jun;67(6):1313-21. doi: 10.1007/s00280-010-1421-y. Epub 2010 Aug 24.

PMID:
20734049
18.

Diurnal variation of the human adipose transcriptome and the link to metabolic disease.

Loboda A, Kraft WK, Fine B, Joseph J, Nebozhyn M, Zhang C, He Y, Yang X, Wright C, Morris M, Chalikonda I, Ferguson M, Emilsson V, Leonardson A, Lamb J, Dai H, Schadt E, Greenberg HE, Lum PY.

BMC Med Genomics. 2009 Feb 9;2:7. doi: 10.1186/1755-8794-2-7.

19.

Minimal effects of ritonavir and efavirenz on the pharmacokinetics of raltegravir.

Iwamoto M, Wenning LA, Petry AS, Laethem M, De Smet M, Kost JT, Breidinger SA, Mangin EC, Azrolan N, Greenberg HE, Haazen W, Stone JA, Gottesdiener KM, Wagner JA.

Antimicrob Agents Chemother. 2008 Dec;52(12):4338-43. doi: 10.1128/AAC.01543-07. Epub 2008 Oct 6.

20.

Effect of aprepitant on the pharmacokinetics of intravenous midazolam.

Majumdar AK, Yan KX, Selverian DV, Barlas S, Constanzer M, Dru J, McCrea JB, Ahmed T, Frick GS, Kraft WK, Petty KJ, Greenberg HE.

J Clin Pharmacol. 2007 Jun;47(6):744-50. Epub 2007 Apr 26.

PMID:
17463213
21.

Transgenic avian-derived recombinant human interferon-alpha2b (AVI-005) in healthy subjects: an open-label, single-dose, controlled study.

Patel TB, Pequignot E, Parker SH, Leavitt MC, Greenberg HE, Kraft WK.

Int J Clin Pharmacol Ther. 2007 Mar;45(3):161-8.

PMID:
17416111
22.

The pharmacokinetics of taurolidine metabolites in healthy volunteers.

Gong L, Greenberg HE, Perhach JL, Waldman SA, Kraft WK.

J Clin Pharmacol. 2007 Jun;47(6):697-703. Epub 2007 Mar 29.

PMID:
17395893
23.

American College of Clinical Pharmacology position statement on the use of microdosing in the drug development process.

Bertino JS Jr, Greenberg HE, Reed MD; American College of Clinical Pharmacology.

J Clin Pharmacol. 2007 Apr;47(4):418-22. No abstract available.

PMID:
17389550
24.

Human pharmacokinetics and interconversion of enantiomers of MK-0767, a dual PPARalpha/gamma agonist.

Rippley RK, Yan KX, Matthews ND, Greenberg HE, Herman GA, Wagner JA.

J Clin Pharmacol. 2007 Mar;47(3):323-33.

PMID:
17322144
25.

Effects of ezetimibe on cyclosporine pharmacokinetics in healthy subjects.

Bergman AJ, Burke J, Larson P, Johnson-Levonas AO, Reyderman L, Statkevich P, Kosoglou T, Greenberg HE, Kraft WK, Frick G, Murphy G, Gottesdiener K, Paolini JF.

J Clin Pharmacol. 2006 Mar;46(3):321-7.

PMID:
16490808
26.

Pharmacokinetics of aprepitant after single and multiple oral doses in healthy volunteers.

Majumdar AK, Howard L, Goldberg MR, Hickey L, Constanzer M, Rothenberg PL, Crumley TM, Panebianco D, Bradstreet TE, Bergman AJ, Waldman SA, Greenberg HE, Butler K, Knops A, De Lepeleire I, Michiels N, Petty KJ.

J Clin Pharmacol. 2006 Mar;46(3):291-300.

PMID:
16490805
27.

The effects of modifying in vivo cytochrome P450 3A (CYP3A) activity on etoricoxib pharmacokinetics and of etoricoxib administration on CYP3A activity.

Agrawal NG, Matthews CZ, Mazenko RS, Woolf EJ, Porras AG, Chen X, Miller JL, Michiels N, Wehling M, Schultz A, Gottlieb AB, Kraft WK, Greenberg HE, Waldman SA, Curtis SP, Gottesdiener KM.

J Clin Pharmacol. 2004 Oct;44(10):1125-31.

PMID:
15342613
28.

Indinavir and rifabutin drug interactions in healthy volunteers.

Kraft WK, McCrea JB, Winchell GA, Carides A, Lowry R, Woolf EJ, Kusma SE, Deutsch PJ, Greenberg HE, Waldman SA.

J Clin Pharmacol. 2004 Mar;44(3):305-13.

PMID:
14973305
29.

The pharmacokinetics of nebulized nanocrystal budesonide suspension in healthy volunteers.

Kraft WK, Steiger B, Beussink D, Quiring JN, Fitzgerald N, Greenberg HE, Waldman SA.

J Clin Pharmacol. 2004 Jan;44(1):67-72.

PMID:
14681343
30.

Effect of mibefradil on CYP3A4 in vivo.

Veronese ML, Gillen LP, Dorval EP, Hauck WW, Waldman SA, Greenberg HE.

J Clin Pharmacol. 2003 Oct;43(10):1091-100.

PMID:
14517191
31.

Relationship of arachidonic acid concentration to cyclooxygenase-dependent human platelet aggregation.

Burke J, Kraft WK, Greenberg HE, Gleave M, Pitari GM, VanBuren S, Wagner JA, Waldman SA.

J Clin Pharmacol. 2003 Sep;43(9):983-9.

PMID:
12971030
32.

Exposure-dependent inhibition of intestinal and hepatic CYP3A4 in vivo by grapefruit juice.

Veronese ML, Gillen LP, Burke JP, Dorval EP, Hauck WW, Pequignot E, Waldman SA, Greenberg HE.

J Clin Pharmacol. 2003 Aug;43(8):831-9.

PMID:
12953340
33.

Effects of aprepitant on the pharmacokinetics of ondansetron and granisetron in healthy subjects.

Blum RA, Majumdar A, McCrea J, Busillo J, Orlowski LH, Panebianco D, Hesney M, Petty KJ, Goldberg MR, Murphy MG, Gottesdiener KM, Hustad CM, Lates C, Kraft WK, Van Buren S, Waldman SA, Greenberg HE.

Clin Ther. 2003 May;25(5):1407-19. Review.

PMID:
12867217
34.

Corticosteroid responsive fludarabine pulmonary toxicity.

Stoica GS, Greenberg HE, Rossoff LJ.

Am J Clin Oncol. 2002 Aug;25(4):340-1.

PMID:
12151960
35.

In-vitro metabolism of celecoxib, a cyclooxygenase-2 inhibitor, by allelic variant forms of human liver microsomal cytochrome P450 2C9: correlation with CYP2C9 genotype and in-vivo pharmacokinetics.

Tang C, Shou M, Rushmore TH, Mei Q, Sandhu P, Woolf EJ, Rose MJ, Gelmann A, Greenberg HE, De Lepeleire I, Van Hecken A, De Schepper PJ, Ebel DL, Schwartz JI, Rodrigues AD.

Pharmacogenetics. 2001 Apr;11(3):223-35.

PMID:
11337938
36.

A new cyclooxygenase-2 inhibitor, rofecoxib (VIOXX), did not alter the antiplatelet effects of low-dose aspirin in healthy volunteers.

Greenberg HE, Gottesdiener K, Huntington M, Wong P, Larson P, Wildonger L, Gillen L, Dorval E, Waldman SA.

J Clin Pharmacol. 2000 Dec;40(12 Pt 2):1509-15.

PMID:
11185674
37.

Simvastatin does not affect CYP3A activity, quantified by the erythromycin breath test and oral midazolam pharmacokinetics, in healthy male subjects.

Prueksaritanont T, Vega JM, Rogers JD, Gagliano K, Greenberg HE, Gillen L, Brucker MJ, McLoughlin D, Wong PH, Waldman SA.

J Clin Pharmacol. 2000 Nov;40(11):1274-9.

PMID:
11075313
38.

Chronic-intermittent hypoxia induces immediate early gene expression in the midline thalamus and epithalamus.

Sica AL, Greenberg HE, Scharf SM, Ruggiero DA.

Brain Res. 2000 Nov 17;883(2):224-8.

PMID:
11074051
39.

Chronic-intermittent hypoxia: a model of sympathetic activation in the rat.

Sica AL, Greenberg HE, Ruggiero DA, Scharf SM.

Respir Physiol. 2000 Jul;121(2-3):173-84. Review.

PMID:
10963773
40.

Pharmacokinetics and safety of single intravenous infusions of the adenosine agonist, AMP 579, in patients with end-stage renal insufficiency.

Zannikos PN, Jensen BK, Boutouyrie BX, Tripp L, Yongyi L, McGowan T, Waldman SA, Greenberg HE.

J Clin Pharmacol. 2000 Jul;40(7):745-51.

PMID:
10883416
41.

Immediate-early gene expression in cerebral cortex following exposure to chronic-intermittent hypoxia.

Sica AL, Greenberg HE, Scharf SM, Ruggiero DA.

Brain Res. 2000 Jul 7;870(1-2):204-10.

PMID:
10869520
42.

Antiplatelet effects of MK-852, a platelet fibrinogen receptor antagonist, in healthy volunteers.

Greenberg HE, Wissel P, Barrett J, Barchowsky A, Gould R, Farrell D, Panebianco D, Hand E, Gillen L, Goldberg MR, Bjornsson TD.

J Clin Pharmacol. 2000 May;40(5):496-507.

PMID:
10806603
43.

Chronic intermittent hypoxia increases sympathetic responsiveness to hypoxia and hypercapnia.

Greenberg HE, Sica A, Batson D, Scharf SM.

J Appl Physiol (1985). 1999 Jan;86(1):298-305.

44.

Expression of c-fos in the rat brainstem after chronic intermittent hypoxia.

Greenberg HE, Sica AL, Scharf SM, Ruggiero DA.

Brain Res. 1999 Jan 23;816(2):638-45.

PMID:
9878890
45.

Paradoxical hypotension and bradycardia after intravenous arginine vasopressin.

Kraft W, Greenberg HE, Waldman SA.

J Clin Pharmacol. 1998 Mar;38(3):283-6.

PMID:
9549667
46.

Time of peak drug concentration after a single dose and a dose at steady state.

Greenberg HE, England MJ, Hellriegel ET, Bjornsson TD.

J Clin Pharmacol. 1997 Jun;37(6):480-5.

PMID:
9208354
47.

gamma-Aminobutyric acid contributes to modulation of cardiorespiratory control after chronic ventilatory loading.

Rao RS, Greenberg HE, Sica AL, Scharf SM.

Respir Physiol. 1997 Apr;108(1):35-44.

PMID:
9178375
48.

Effect of chronic resistive loading on hypoxic ventilatory responsiveness.

Greenberg HE, Rao RS, Sica AL, Scharf SM.

J Appl Physiol (1985). 1997 Feb;82(2):500-7.

49.

Effect of beta-carboline-3-carboxoylate-t-butyl ester on ventilatory control.

Greenberg HE, Scharf M, Mendelson W, Cook JM, Cox E, Scharf SM.

Life Sci. 1997;60(7):485-92.

PMID:
9042377
50.

Sleep quality in Lyme disease.

Greenberg HE, Ney G, Scharf SM, Ravdin L, Hilton E.

Sleep. 1995 Dec;18(10):912-6.

PMID:
8746401

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