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Items: 1 to 50 of 89

1.

Evaluation of the Effect of 5 QT-Positive Drugs on the JTpeak Interval - An Analysis of ECGs From the IQ-CSRC Study.

Darpo B, Benson C, Brown R, Dota C, Ferber G, Ferry J, Jarugula V, Keirns J, Ortemann-Renon C, Pham T, Riley S, Sarapa N, Ticktin M, Zareba W, Couderc JP.

J Clin Pharmacol. 2019 Aug 5. doi: 10.1002/jcph.1502. [Epub ahead of print]

PMID:
31378962
2.

Population pharmacokinetics of immediate- and prolonged-release tacrolimus formulations in liver, kidney and heart transplant recipients.

Lu Z, Bonate P, Keirns J.

Br J Clin Pharmacol. 2019 Aug;85(8):1692-1703. doi: 10.1111/bcp.13952. Epub 2019 Jun 7.

3.

The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies.

Kusawake T, Kowalski D, Takada A, Kato K, Katashima M, Keirns JJ, Lewand M, Lasseter KC, Marbury TC, Preston RA.

Adv Ther. 2017 Dec;34(12):2612-2624. doi: 10.1007/s12325-017-0643-3. Epub 2017 Nov 13.

4.

Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies.

Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M.

Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.

5.

The Effect of Verapamil, a P-Glycoprotein Inhibitor, on the Pharmacokinetics of Peficitinib, an Orally Administered, Once-Daily JAK Inhibitor.

Zhu T, Howieson C, Wojtkowski T, Garg JP, Han D, Fisniku O, Keirns J.

Clin Pharmacol Drug Dev. 2017 Nov;6(6):548-555. doi: 10.1002/cpdd.344. Epub 2017 Mar 16.

PMID:
28301084
6.

QT Interval Shortening With Isavuconazole: In Vitro and In Vivo Effects on Cardiac Repolarization.

Keirns J, Desai A, Kowalski D, Lademacher C, Mujais S, Parker B, Schneidkraut MJ, Townsend R, Wojtkowski T, Yamazaki T, Yen M, Kowey PR.

Clin Pharmacol Ther. 2017 Jun;101(6):782-790. doi: 10.1002/cpt.620. Epub 2017 Feb 13.

7.

Drug Interactions Between Peficitinib, an Orally Administered, Once-Daily Janus Kinase Inhibitor, and Rosuvastatin in Healthy Subjects.

Zhu T, Parker B, Wojtkowski T, Nishimura T, Garg JP, Han D, Fisniku O, Keirns J.

Clin Pharmacokinet. 2017 Jul;56(7):747-757. doi: 10.1007/s40262-016-0474-4.

PMID:
27878567
8.

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ASP2408, a Potent Selective T-Cell Costimulation Modulator After Single and Multiple Ascending Doses in Healthy Volunteers and RA Patients.

Zhu T, Keirns J, Howieson C, Kaibara A, Goldwater R, Kivitz AJ, Chindalore V, Cohen S, Santos V, Akinlade B, Kernstock R, Delgado-Herrera L, Blahunka PC, Karrer EE, Garg JP, Samberg N, Zeiher BG.

Clin Pharmacol Drug Dev. 2016 Sep;5(5):408-25. doi: 10.1002/cpdd.251. Epub 2016 Mar 28.

PMID:
27410490
9.

Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?

Ferber G, Zhou M, Dota C, Garnett C, Keirns J, Malik M, Stockbridge N, Darpo B.

J Clin Pharmacol. 2017 Jan;57(1):85-95. doi: 10.1002/jcph.779. Epub 2016 Jul 7.

PMID:
27271102
10.

Pharmacokinetics of prolonged-release tacrolimus and implications for use in solid organ transplant recipients.

Tanzi MG, Undre N, Keirns J, Fitzsimmons WE, Brown M, First MR.

Clin Transplant. 2016 Aug;30(8):901-11. doi: 10.1111/ctr.12763. Epub 2016 Jun 18. Review.

PMID:
27220013
11.

Pharmacokinetics, Pharmacodynamics, and Safety of ASP015K (Peficitinib), a New Janus Kinase Inhibitor, in Healthy Subjects.

Cao YJ, Sawamoto T, Valluri U, Cho K, Lewand M, Swan S, Lasseter K, Matson M, Holman J Jr, Keirns J, Zhu T.

Clin Pharmacol Drug Dev. 2016 Nov;5(6):435-449. doi: 10.1002/cpdd.273. Epub 2016 Jun 30.

PMID:
27162173
12.

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.

PMID:
27052879
13.

Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.

Darpo B, Garnett C, Keirns J, Stockbridge N.

Drug Saf. 2015 Sep;38(9):773-80. doi: 10.1007/s40264-015-0325-5.

PMID:
26162419
14.

Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.

Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N.

Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60.

PMID:
25670536
15.

Reproducibility of QTc interval changes after meal intake.

Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM, Malik M.

J Electrocardiol. 2015 Mar-Apr;48(2):194-202. doi: 10.1016/j.jelectrocard.2015.01.006. Epub 2015 Jan 8.

PMID:
25601409
16.

Are QTc interval changes after meal intake a reasonable method to prove assay sensitivity in thorough QT studies?

Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM, Malik M.

J Electrocardiol. 2015 Mar-Apr;48(2):276-7. doi: 10.1016/j.jelectrocard.2015.01.005. Epub 2015 Jan 6. No abstract available.

PMID:
25578392
17.

Clinical pharmacokinetics and pharmacodynamics of the novel SGLT2 inhibitor ipragliflozin.

Kadokura T, Zhang W, Krauwinkel W, Leeflang S, Keirns J, Taniuchi Y, Nakajo I, Smulders R.

Clin Pharmacokinet. 2014 Nov;53(11):975-88. doi: 10.1007/s40262-014-0180-z. Review.

PMID:
25316572
18.

QTc changes after meal intake: sex differences and correlates.

Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM, Malik M.

J Electrocardiol. 2014 Nov-Dec;47(6):856-62. doi: 10.1016/j.jelectrocard.2014.07.026. Epub 2014 Aug 2.

PMID:
25173631
19.

Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward.

Darpo B, Garnett C, Benson CT, Keirns J, Leishman D, Malik M, Mehrotra N, Prasad K, Riley S, Rodriguez I, Sager P, Sarapa N, Wallis R.

Am Heart J. 2014 Sep;168(3):262-72. doi: 10.1016/j.ahj.2014.06.003. Epub 2014 Jun 6.

PMID:
25173536
20.

Statistical analysis of Amenamevir (ASP2151) between pharmacokinetics and clinical efficacies with non-linear effect model for the treatment of genital herpes.

Takada A, Katashima M, Kaibara A, Sawamoto T, Zhang W, Keirns J.

Clin Pharmacol Drug Dev. 2014 Sep;3(5):365-70. doi: 10.1002/cpdd.108. Epub 2014 Feb 17.

PMID:
27129009
21.

ICH E14-compatible holter bin method and its equivalence to individual heart rate correction in the assessment of drug-induced QT changes.

Malik M, Hnatkova K, Kowalski D, Keirns JJ, Van Gelderen EM.

J Cardiovasc Electrophysiol. 2014 Nov;25(11):1232-41. doi: 10.1111/jce.12450. Epub 2014 Jun 11.

PMID:
24801246
22.

Have individual QT/RR curvatures value in QT correction?

Malik M, Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM.

J Electrocardiol. 2014 May-Jun;47(3):386-91. doi: 10.1016/j.jelectrocard.2014.01.010. Epub 2014 Jan 31. No abstract available.

PMID:
24698409
23.

Assessment of tacrolimus absorption from the human intestinal tract: open-label, randomized, 4-way crossover study.

Tsunashima D, Kawamura A, Murakami M, Sawamoto T, Undre N, Brown M, Groenewoud A, Keirns JJ, Holman J, Connor A, Wylde H, Wilding I, Ogawara K, Sako K, Higaki K, First R.

Clin Ther. 2014 May;36(5):748-59. doi: 10.1016/j.clinthera.2014.02.021. Epub 2014 Mar 27.

PMID:
24680768
24.

The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

Darpo B, Sarapa N, Garnett C, Benson C, Dota C, Ferber G, Jarugula V, Johannesen L, Keirns J, Krudys K, Ortemann-Renon C, Riley S, Rogers-Subramaniam D, Stockbridge N.

Ann Noninvasive Electrocardiol. 2014 Jan;19(1):70-81. doi: 10.1111/anec.12128. Epub 2013 Dec 30. Review.

PMID:
24372708
25.

QT/RR curvatures in healthy subjects: sex differences and covariates.

Malik M, Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM.

Am J Physiol Heart Circ Physiol. 2013 Dec;305(12):H1798-806. doi: 10.1152/ajpheart.00577.2013. Epub 2013 Oct 25.

26.

Relationship of QT interval variability to heart rate and RR interval variability.

Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM, Malik M.

J Electrocardiol. 2013 Nov-Dec;46(6):591-6. doi: 10.1016/j.jelectrocard.2013.07.007. Epub 2013 Aug 9.

PMID:
23938108
27.

Ipragliflozin does not prolong QTc interval in healthy male and female subjects: a phase I study.

Zhang W, Smulders R, Abeyratne A, Dietz A, Krauwinkel W, Kadokura T, Keirns J.

Clin Ther. 2013 Aug;35(8):1150-1161.e3. doi: 10.1016/j.clinthera.2013.06.009. Epub 2013 Aug 2.

PMID:
23910665
28.

The effect of moderate hepatic impairment on the pharmacokinetics of ipragliflozin, a novel sodium glucose co-transporter 2 (SGLT2) inhibitor.

Zhang W, Krauwinkel WJ, Keirns J, Townsend RW, Lasseter KC, Plumb L, Kadokura T, Ushigome F, Smulders R.

Clin Drug Investig. 2013 Jul;33(7):489-96. doi: 10.1007/s40261-013-0089-6.

PMID:
23733389
29.

Role of cytochrome p450 isoenzymes 3A and 2D6 in the in vivo metabolism of mirabegron, a β3-adrenoceptor agonist.

Lee J, Moy S, Meijer J, Krauwinkel W, Sawamoto T, Kerbusch V, Kowalski D, Roy M, Marion A, Takusagawa S, van Gelderen M, Keirns J.

Clin Drug Investig. 2013 Jun;33(6):429-40. doi: 10.1007/s40261-013-0084-y.

PMID:
23625188
30.

Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.

Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M, Sawamoto T, Grunenberg N, Keirns J.

Clin Ther. 2013 Mar;35(3):333-41. doi: 10.1016/j.clinthera.2013.02.014.

PMID:
23497763
31.

Pharmacokinetics of intravenous conivaptan in subjects with hepatic or renal impairment.

Roy MJ, Erdman KA, Abeyratne AT, Plumb LC, Lasseter K, Riff DS, Keirns JJ.

Clin Pharmacokinet. 2013 May;52(5):385-95. doi: 10.1007/s40262-013-0047-8.

PMID:
23456393
32.

A phase 1, randomized ascending single-dose study of antagonist anti-human CD40 ASKP1240 in healthy subjects.

Goldwater R, Keirns J, Blahunka P, First R, Sawamoto T, Zhang W, Kowalski D, Kaibara A, Holman J.

Am J Transplant. 2013 Apr;13(4):1040-1046. doi: 10.1111/ajt.12082. Epub 2013 Jan 28.

33.

Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron.

Dickinson J, Lewand M, Sawamoto T, Krauwinkel W, Schaddelee M, Keirns J, Kerbusch V, Moy S, Meijer J, Kowalski D, Morton R, Lasseter K, Riff D, Kupčová V, van Gelderen M.

Clin Drug Investig. 2013 Jan;33(1):11-23. doi: 10.1007/s40261-012-0031-3.

PMID:
23208320
34.

Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study.

Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R, Mujais SK, Schaddelee MP, de Koning P, Kaibara A, Moy SS, Keirns JJ.

Clin Pharmacol Ther. 2012 Dec;92(6):696-706. doi: 10.1038/clpt.2012.181. Epub 2012 Nov 14.

PMID:
23149929
35.

Importance of subject-specific QT/RR curvatures in the design of individual heart rate corrections of the QT interval.

Malik M, Hnatkova K, Kowalski D, Keirns JJ, van Gelderen EM.

J Electrocardiol. 2012 Nov-Dec;45(6):571-81. doi: 10.1016/j.jelectrocard.2012.07.017. Epub 2012 Sep 20.

PMID:
22999325
36.

No pharmacokinetic interaction between ipragliflozin and sitagliptin, pioglitazone, or glimepiride in healthy subjects.

Smulders RA, Zhang W, Veltkamp SA, van Dijk J, Krauwinkel WJ, Keirns J, Kadokura T.

Diabetes Obes Metab. 2012 Oct;14(10):937-43. doi: 10.1111/j.1463-1326.2012.01624.x. Epub 2012 Jun 7.

PMID:
22587345
37.

Population pharmacokinetic-pharmacodynamic analysis of vernakalant hydrochloride injection (RSD1235) in atrial fibrillation or atrial flutter.

Mao Z, Wheeler JJ, Townsend R, Gao Y, Kshirsagar S, Keirns JJ.

J Pharmacokinet Pharmacodyn. 2011 Oct;38(5):541-62. doi: 10.1007/s10928-011-9207-3. Epub 2011 Jul 24.

PMID:
21786177
38.

Population pharmacokinetics of vernakalant hydrochloride injection (RSD1235) in patients with atrial fibrillation or atrial flutter.

Mao ZL, Townsend RW, Gao Y, Wheeler JJ, Kastrissios H, Keirns J.

J Clin Pharmacol. 2012 Jul;52(7):1042-53. doi: 10.1177/0091270011408425. Epub 2011 Jun 9.

PMID:
21659624
39.

Disposition and mass balance of [14C]vernakalant after single intravenous and oral doses in healthy volunteers.

Mao ZL, Alak A, Wheeler JJ, Keirns J.

Drug Metab Lett. 2011 Apr;5(2):114-25.

PMID:
21457140
40.

Clinical pharmacology, biomarkers and personalized medicine: education please.

de Koning P, Keirns J.

Biomark Med. 2009 Dec;3(6):685-700. doi: 10.2217/bmm.09.53.

PMID:
20477707
42.

Pharmacokinetics of novel atrial-selective antiarrhythmic agent vernakalant hydrochloride injection (RSD1235): influence of CYP2D6 expression and other factors.

Mao ZL, Wheeler JJ, Clohs L, Beatch GN, Keirns J.

J Clin Pharmacol. 2009 Jan;49(1):17-29. doi: 10.1177/0091270008325148. Epub 2008 Oct 16.

PMID:
18927241
43.

The pharmacokinetics and pharmacodynamics of micafungin in experimental hematogenous Candida meningoencephalitis: implications for echinocandin therapy in neonates.

Hope WW, Mickiene D, Petraitis V, Petraitiene R, Kelaher AM, Hughes JE, Cotton MP, Bacher J, Keirns JJ, Buell D, Heresi G, Benjamin DK Jr, Groll AH, Drusano GL, Walsh TJ.

J Infect Dis. 2008 Jan 1;197(1):163-71. doi: 10.1086/524063.

44.

Population pharmacokinetics of micafungin in adult patients.

Gumbo T, Hiemenz J, Ma L, Keirns JJ, Buell DN, Drusano GL.

Diagn Microbiol Infect Dis. 2008 Mar;60(3):329-31. Epub 2007 Nov 19.

PMID:
18024052
45.

Population pharmacokinetics of micafungin in pediatric patients and implications for antifungal dosing.

Hope WW, Seibel NL, Schwartz CL, Arrieta A, Flynn P, Shad A, Albano E, Keirns JJ, Buell DN, Gumbo T, Drusano GL, Walsh TJ.

Antimicrob Agents Chemother. 2007 Oct;51(10):3714-9. Epub 2007 Jul 16.

46.

Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients.

Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR.

Am J Transplant. 2007 Jun;7(6):1609-15.

47.

Pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adult and pediatric patients with moderate to severe atopic dermatitis.

Krueger GG, Eichenfield L, Goodman JJ, Krafchik BR, Carlin CS, Pang ML, Croy R, Holum ME, Jaracz E, Sawamoto T, Keirns J.

J Drugs Dermatol. 2007 Feb;6(2):185-93.

PMID:
17373177
48.

The pharmacokinetics and safety of micafungin, a novel echinocandin, in premature infants.

Heresi GP, Gerstmann DR, Reed MD, van den Anker JN, Blumer JL, Kovanda L, Keirns JJ, Buell DN, Kearns GL.

Pediatr Infect Dis J. 2006 Dec;25(12):1110-5.

PMID:
17133155
49.

Steady-state pharmacokinetics of micafungin and voriconazole after separate and concomitant dosing in healthy adults.

Keirns J, Sawamoto T, Holum M, Buell D, Wisemandle W, Alak A.

Antimicrob Agents Chemother. 2007 Feb;51(2):787-90. Epub 2006 Nov 20.

50.

Pharmacokinetics of micafungin in healthy volunteers, volunteers with moderate liver disease, and volunteers with renal dysfunction.

Hebert MF, Smith HE, Marbury TC, Swan SK, Smith WB, Townsend RW, Buell D, Keirns J, Bekersky I.

J Clin Pharmacol. 2005 Oct;45(10):1145-52.

PMID:
16172179

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