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Items: 1 to 50 of 53

1.

Physiologically-Based Pharmacokinetic Modelling to Predict Exposure Differences in Healthy Volunteers and Subjects with Renal Impairment: Ceftazidime Case Study.

Zhou L, Tong X, Sharma P, Xu H, Al-Huniti N, Zhou D.

Basic Clin Pharmacol Toxicol. 2019 Feb 9. doi: 10.1111/bcpt.13209. [Epub ahead of print]

PMID:
30739396
2.

Population pharmacokinetic analysis of danvatirsen supporting flat dosing switch.

Xu H, Tong X, Mugundu G, Scott ML, Cook C, Arfvidsson C, Pease E, Zhou D, Lyne P, Al-Huniti N.

J Pharmacokinet Pharmacodyn. 2019 Feb;46(1):65-74. doi: 10.1007/s10928-019-09619-6. Epub 2019 Jan 19.

PMID:
30661177
3.

Efficacy and Safety Exposure-Response Analyses of Olaparib Capsule and Tablet formulations in Oncology Patients.

Zhou D, Li J, Learoyd M, Bui K, Berges A, Milenkova T, Al-Huniti N, Tomkinson H, Xu H.

Clin Pharmacol Ther. 2018 Dec 26. doi: 10.1002/cpt.1338. [Epub ahead of print]

PMID:
30585620
4.

Population Pharmacokinetics of the BTK Inhibitor Acalabrutinib and its Active Metabolite in Healthy Volunteers and Patients with B-Cell Malignancies.

Edlund H, Lee SK, Andrew MA, Slatter JG, Aksenov S, Al-Huniti N.

Clin Pharmacokinet. 2018 Dec 17. doi: 10.1007/s40262-018-0725-7. [Epub ahead of print]

PMID:
30556110
5.

Joint longitudinal and time-to-event models for multilevel hierarchical data.

Brilleman SL, Crowther MJ, Moreno-Betancur M, Buros Novik J, Dunyak J, Al-Huniti N, Fox R, Hammerbacher J, Wolfe R.

Stat Methods Med Res. 2018 Oct 31:962280218808821. doi: 10.1177/0962280218808821. [Epub ahead of print]

PMID:
30378472
6.

Bridging Olaparib Capsule and Tablet Formulations Using Population Pharmacokinetic Meta-analysis in Oncology Patients.

Zhou D, Li J, Bui K, Learoyd M, Berges A, Milenkova T, Al-Huniti N, Tomkinson H, Xu H.

Clin Pharmacokinet. 2018 Oct 24. doi: 10.1007/s40262-018-0714-x. [Epub ahead of print]

PMID:
30357650
7.

Simplified Aztreonam Dosing in Patients with End-Stage Renal Disease: Results of a Monte Carlo Simulation.

Gross AE, Xu H, Zhou D, Al-Huniti N.

Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e01066-18. doi: 10.1128/AAC.01066-18. Print 2018 Nov.

PMID:
30150467
8.

Population Pharmacokinetic and Exposure-Response Analysis of Selumetinib and Its N-desmethyl Metabolite in Patients With Non-Small Cell Lung Cancer.

Tong X, Xu H, Carlile DJ, Tomkinson H, Al-Huniti N, Zhou D.

J Clin Pharmacol. 2019 Jan;59(1):112-122. doi: 10.1002/jcph.1295. Epub 2018 Aug 13.

PMID:
30102413
9.

Population Pharmacokinetic Modeling With Enterohepatic Circulation for AZD3241 in Healthy Subjects and Patients With Multiple System Atrophy.

Tong X, Zhou D, Savage A, Mullen JA, Li Y, Taylor W, Li J, Al-Huniti N, Xu H.

J Clin Pharmacol. 2018 Nov;58(11):1452-1460. doi: 10.1002/jcph.1134. Epub 2018 Jun 6.

PMID:
29873817
10.

The Identification of Potent, Selective, and Orally Available Inhibitors of Ataxia Telangiectasia Mutated (ATM) Kinase: The Discovery of AZD0156 (8-{6-[3-(Dimethylamino)propoxy]pyridin-3-yl}-3-methyl-1-(tetrahydro-2 H-pyran-4-yl)-1,3-dihydro-2 H-imidazo[4,5- c]quinolin-2-one).

Pike KG, Barlaam B, Cadogan E, Campbell A, Chen Y, Colclough N, Davies NL, de-Almeida C, Degorce SL, Didelot M, Dishington A, Ducray R, Durant ST, Hassall LA, Holmes J, Hughes GD, MacFaul PA, Mulholland KR, McGuire TM, Ouvry G, Pass M, Robb G, Stratton N, Wang Z, Wilson J, Zhai B, Zhao K, Al-Huniti N.

J Med Chem. 2018 May 10;61(9):3823-3841. doi: 10.1021/acs.jmedchem.7b01896. Epub 2018 May 2.

PMID:
29683659
11.

Assessing QT/QTc interval prolongation with concentration-QT modeling for Phase I studies: impact of computational platforms, model structures and confidence interval calculation methods.

Lu J, Li J, Helmlinger G, Al-Huniti N.

J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):469-482. doi: 10.1007/s10928-018-9582-0. Epub 2018 Mar 19.

PMID:
29556866
12.

Radiation and PD-(L)1 treatment combinations: immune response and dose optimization via a predictive systems model.

Kosinsky Y, Dovedi SJ, Peskov K, Voronova V, Chu L, Tomkinson H, Al-Huniti N, Stanski DR, Helmlinger G.

J Immunother Cancer. 2018 Feb 27;6(1):17. doi: 10.1186/s40425-018-0327-9.

13.

Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use.

Nayak S, Sander O, Al-Huniti N, de Alwis D, Chain A, Chenel M, Sunkaraneni S, Agrawal S, Gupta N, Visser SAG.

Clin Pharmacol Ther. 2018 Mar;103(3):378-383. doi: 10.1002/cpt.978. Epub 2018 Jan 13. Erratum in: Clin Pharmacol Ther. 2018 Nov;104(5):1031.

14.

Integrating dose estimation into a decision-making framework for model-based drug development.

Dunyak J, Mitchell P, Hamrén B, Helmlinger G, Matcham J, Stanski D, Al-Huniti N.

Pharm Stat. 2018 Mar;17(2):155-168. doi: 10.1002/pst.1841. Epub 2018 Jan 10.

PMID:
29322659
15.

Population exposure-safety analysis of cediranib for Phase I and II studies in patients with cancer.

Al-Huniti N, Petersson K, Tang W, Masson E, Li J.

Br J Clin Pharmacol. 2018 Apr;84(4):726-737. doi: 10.1111/bcp.13495. Epub 2018 Jan 31.

PMID:
29274100
16.

Physiologically Based Pharmacokinetic Modeling to Evaluate the Systemic Exposure of Gefitinib in CYP2D6 Ultrarapid Metabolizers and Extensive Metabolizers.

Chen Y, Zhou D, Tang W, Zhou W, Al-Huniti N, Masson E.

J Clin Pharmacol. 2018 Apr;58(4):485-493. doi: 10.1002/jcph.1036. Epub 2017 Nov 28.

PMID:
29193123
17.

Predictive Performance of Physiologically Based Pharmacokinetic (PBPK) Modeling of Drugs Extensively Metabolized by Major Cytochrome P450s in Children.

Zhou W, Johnson TN, Bui KH, Cheung SYA, Li J, Xu H, Al-Huniti N, Zhou D.

Clin Pharmacol Ther. 2018 Jul;104(1):188-200. doi: 10.1002/cpt.905. Epub 2017 Nov 20.

PMID:
29027194
18.

Population Exposure-Response Modeling Supported Selection of Naloxegol Doses in Phase III Studies in Patients With Opioid-Induced Constipation.

Al-Huniti N, Xu H, Zhou D, Aksenov S, Fox R, Bui KH.

CPT Pharmacometrics Syst Pharmacol. 2017 Oct;6(10):705-711. doi: 10.1002/psp4.12229. Epub 2017 Sep 25.

19.

Population Pharmacokinetic Analysis of Zolmitriptan and Its Metabolite in Adults and Adolescents to Support Dose Selection in Children With Migraine.

Zhou W, Li J, Birmingham B, Xu H, Lillieborg S, Zhou D, Al-Huniti N.

J Clin Pharmacol. 2017 Oct;57(10):1258-1267. doi: 10.1002/jcph.935. Epub 2017 Jun 5.

PMID:
28581633
20.

Pharmacometric Modeling of Naloxegol Efficacy and Safety: Impact on Dose and Label.

Al-Huniti N, Zhou D, Xu H, Aksenov S, Bui KH, Fox R, Helmlinger G, Stanski D.

Clin Pharmacol Ther. 2017 Nov;102(5):741-744. doi: 10.1002/cpt.719. Epub 2017 May 26. Review.

PMID:
28548207
21.

Drug-disease modeling in the pharmaceutical industry - where mechanistic systems pharmacology and statistical pharmacometrics meet.

Helmlinger G, Al-Huniti N, Aksenov S, Peskov K, Hallow KM, Chu L, Boulton D, Eriksson U, Hamrén B, Lambert C, Masson E, Tomkinson H, Stanski D.

Eur J Pharm Sci. 2017 Nov 15;109S:S39-S46. doi: 10.1016/j.ejps.2017.05.028. Epub 2017 May 12. Review.

PMID:
28506868
22.

Development of a physiologically based pharmacokinetic model to predict the effects of flavin-containing monooxygenase 3 (FMO3) polymorphisms on itopride exposure.

Zhou W, Humphries H, Neuhoff S, Gardner I, Masson E, Al-Huniti N, Zhou D.

Biopharm Drug Dispos. 2017 Sep;38(6):389-393. doi: 10.1002/bdd.2074. Epub 2017 May 28.

PMID:
28255999
23.

Population pharmacokinetic and exposure simulation analysis for cediranib (AZD2171) in pooled Phase I/II studies in patients with cancer.

Li J, Al-Huniti N, Henningsson A, Tang W, Masson E.

Br J Clin Pharmacol. 2017 Aug;83(8):1723-1733. doi: 10.1111/bcp.13266. Epub 2017 Mar 27.

24.

Clinical Pharmacokinetics and Pharmacodynamics of Naloxegol, a Peripherally Acting µ-Opioid Receptor Antagonist.

Bui K, Zhou D, Xu H, Floettmann E, Al-Huniti N.

Clin Pharmacokinet. 2017 Jun;56(6):573-582. doi: 10.1007/s40262-016-0479-z. Review.

PMID:
28035588
25.

Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics.

Nguyen TH, Mouksassi MS, Holford N, Al-Huniti N, Freedman I, Hooker AC, John J, Karlsson MO, Mould DR, Pérez Ruixo JJ, Plan EL, Savic R, van Hasselt JG, Weber B, Zhou C, Comets E, Mentré F; Model Evaluation Group of the International Society of Pharmacometrics (ISoP) Best Practice Committee.

CPT Pharmacometrics Syst Pharmacol. 2017 Feb;6(2):87-109. doi: 10.1002/psp4.12161. Epub 2017 Feb 10.

26.

Evaluation of the Effect of Selumetinib on Cardiac Repolarization: A Randomized, Placebo- and Positive-controlled Crossover QT/QTc Study in Healthy Subjects.

Zhou D, So K, Dymond AW, Vik T, Al-Huniti N, Mariani G, Zorenyi G, Huang Y, Holmes V, Severin P, Rasmussen S, Martin P.

Clin Ther. 2016 Dec;38(12):2555-2566. doi: 10.1016/j.clinthera.2016.10.004. Epub 2016 Nov 9.

27.

Predictive Performance of Physiologically Based Pharmacokinetic and Population Pharmacokinetic Modeling of Renally Cleared Drugs in Children.

Zhou W, Johnson TN, Xu H, Cheung S, Bui KH, Li J, Al-Huniti N, Zhou D.

CPT Pharmacometrics Syst Pharmacol. 2016 Sep;5(9):475-83. doi: 10.1002/psp4.12101. Epub 2016 Aug 27.

28.

Evaluation of Aztreonam Dosing Regimens in Patients With Normal and Impaired Renal Function: A Population Pharmacokinetic Modeling and Monte Carlo Simulation Analysis.

Xu H, Zhou W, Zhou D, Li J, Al-Huniti N.

J Clin Pharmacol. 2017 Mar;57(3):336-344. doi: 10.1002/jcph.810. Epub 2016 Sep 14.

PMID:
27530649
29.

Population Exposure-Response Modeling of Naloxegol in Patients With Noncancer-Related Pain and Opioid-Induced Constipation.

Al-Huniti N, Nielsen JC, Hutmacher MM, Lappalainen J, Cantagallo K, Sostek M.

CPT Pharmacometrics Syst Pharmacol. 2016 Jul;5(7):359-66. doi: 10.1002/psp4.12099. Epub 2016 Jul 20.

30.

Simulation and Prediction of the Drug-Drug Interaction Potential of Naloxegol by Physiologically Based Pharmacokinetic Modeling.

Zhou D, Bui K, Sostek M, Al-Huniti N.

CPT Pharmacometrics Syst Pharmacol. 2016 May;5(5):250-7. doi: 10.1002/psp4.12070. Epub 2016 Apr 16.

31.
32.

Effects of CYP3A Modulators on the Pharmacokinetics of Naloxegol.

Bui K, Zhou D, Sostek M, She F, Al-Huniti N.

J Clin Pharmacol. 2016 Aug;56(8):1019-27. doi: 10.1002/jcph.693. Epub 2016 Feb 24.

PMID:
26678015
33.

Population Pharmacokinetic and Pharmacodynamic Modeling of AZD4901 and Simulation to Support Dose Selection for the Phase 2a Study.

Xu H, Li J, Webber L, Kakkar R, Chen Y, Al-Huniti N.

J Clin Pharmacol. 2016 Aug;56(8):999-1008. doi: 10.1002/jcph.680. Epub 2016 Jan 18.

PMID:
26626581
34.

Population pharmacokinetics of naloxegol in a population of 1247 healthy subjects and patients.

Al-Huniti N, Chapel S, Xu H, Bui KH, Sostek M.

Br J Clin Pharmacol. 2016 Jan;81(1):89-100. doi: 10.1111/bcp.12756. Epub 2015 Oct 27.

35.

The effect of quinidine, a strong P-glycoprotein inhibitor, on the pharmacokinetics and central nervous system distribution of naloxegol.

Bui K, She F, Zhou D, Butler K, Al-Huniti N, Sostek M.

J Clin Pharmacol. 2016 Apr;56(4):497-505. doi: 10.1002/jcph.613. Epub 2015 Nov 9.

PMID:
26248047
36.

Reporting guidelines for population pharmacokinetic analyses.

Dykstra K, Mehrotra N, Tornøe CW, Kastrissios H, Patel B, Al-Huniti N, Jadhav P, Wang Y, Byon W.

J Clin Pharmacol. 2015 Aug;55(8):875-87. doi: 10.1002/jcph.532.

PMID:
26148467
37.
38.

Reporting guidelines for population pharmacokinetic analyses.

Dykstra K, Mehrotra N, Tornøe CW, Kastrissios H, Patel B, Al-Huniti N, Jadhav P, Wang Y, Byon W.

J Pharmacokinet Pharmacodyn. 2015 Jun;42(3):301-14. doi: 10.1007/s10928-015-9417-1. Epub 2015 Apr 30.

39.

Population pharmacokinetic modelling to assess clinical drug-drug interaction between AZD7325 and midazolam.

Zhou D, Lu Z, Sunzel M, Xu H, Al-Huniti N.

J Clin Pharm Ther. 2014 Aug;39(4):404-10. doi: 10.1111/jcpt.12152. Epub 2014 Apr 1.

PMID:
24689515
40.

Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies.

Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N.

J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.

PMID:
24408516
41.

Single-dose pharmacokinetics and pharmacodynamics of anacetrapib, a potent cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects.

Krishna R, Garg A, Panebianco D, Cote J, Bergman AJ, Van Hoydonck P, Laethem T, Van Dyck K, Chen J, Chavez-Eng C, Archer L, Lutz R, Hilliard D, Snyder K, Jin B, Van Bortel L, Lasseter KC, Al-Huniti N, Dykstra K, Gottesdiener K, Wagner JA.

Br J Clin Pharmacol. 2009 Oct;68(4):535-45. doi: 10.1111/j.1365-2125.2009.03465.x.

42.

Multiple-dose pharmacodynamics and pharmacokinetics of anacetrapib, a potent cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects.

Krishna R, Bergman AJ, Jin B, Fallon M, Cote J, Van Hoydonck P, Laethem T, Gendrano IN 3rd, Van Dyck K, Hilliard D, Laterza O, Snyder K, Chavez-Eng C, Lutz R, Chen J, Bloomfield DM, De Smet M, Van Bortel LM, Gutierrez M, Al-Huniti N, Dykstra K, Gottesdiener KM, Wagner JA.

Clin Pharmacol Ther. 2008 Dec;84(6):679-83. doi: 10.1038/clpt.2008.109. Epub 2008 Jun 25. No abstract available.

PMID:
18580870
43.

Asthma and insulin resistance in morbidly obese children and adolescents.

Al-Shawwa BA, Al-Huniti NH, DeMattia L, Gershan W.

J Asthma. 2007 Jul-Aug;44(6):469-73.

PMID:
17654134
44.

Change in erythropoietin pharmacokinetics following hematopoietic transplantation.

Widness JA, Schmidt RL, Hohl RJ, Goldman FD, Al-Huniti NH, Freise KJ, Veng-Pedersen P.

Clin Pharmacol Ther. 2007 Jun;81(6):873-9. Epub 2007 Apr 11.

45.

Clinical and therapeutic variables influencing hospitalisation for bronchiolitis in a community-based paediatric group practice.

Al-Shawwa B, Al-Huniti N, Weinberger M, Abu-Hasan M.

Prim Care Respir J. 2007 Apr;16(2):93-7.

46.

Individualized pharmacokinetic risk assessment for development of diabetes in high risk population.

Gupta N, Al-Huniti NH, Veng-Pedersen P.

Diabetes Res Clin Pract. 2007 Oct;78(1):93-101. Epub 2007 Mar 19.

47.

Hypercholesterolemia is a potential risk factor for asthma.

Al-Shawwa B, Al-Huniti N, Titus G, Abu-Hasan M.

J Asthma. 2006 Apr;43(3):231-3.

PMID:
16754527
48.

Pharmacodynamic analysis of changes in reticulocyte subtype distribution in phlebotomy-induced stress erythropoiesis.

Al-Huniti NH, Widness JA, Schmidt RL, Veng-Pedersen P.

J Pharmacokinet Pharmacodyn. 2005 Aug;32(3-4):359-76.

PMID:
16284920
49.

Erythropoietin production rate in phlebotomy-induced acute anemia.

Al-Huniti NH, Widness JA, Schmidt RL, Veng-Pedersen P.

Biopharm Drug Dispos. 2004 Dec;25(9):389-97.

PMID:
15529399
50.

Pharmacokinetic tracer kinetics analysis of changes in erythropoietin receptor population in phlebotomy-induced anemia and bone marrow ablation.

Veng-Pedersen P, Chapel S, Al-Huniti NH, Schmidt RL, Sedars EM, Hohl RJ, Widness JA.

Biopharm Drug Dispos. 2004 May;25(4):149-56.

PMID:
15108217

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