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Items: 25

1.

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
2.

SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer.

Soria JC, Fülöp A, Maciel C, Fischer JR, Girotto G, Lago S, Smit E, Ostoros G, Eberhardt WEE, Lishkovska P, Lovick S, Mariani G, McKeown A, Kilgour E, Smith P, Bowen K, Kohlmann A, Carlile DJ, Jänne PA.

Ann Oncol. 2017 Dec 1;28(12):3028-3036. doi: 10.1093/annonc/mdx628.

3.

Population pharmacokinetics of the MEK inhibitor selumetinib and its active N-desmethyl metabolite: data from 10 phase I trials.

Patel P, Howgate E, Martin P, Carlile DJ, Aarons L, Zhou D.

Br J Clin Pharmacol. 2018 Jan;84(1):52-63. doi: 10.1111/bcp.13404. Epub 2017 Sep 22.

4.

Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial.

Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J.

JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.

5.

Population Pharmacokinetics of Selumetinib and Its Metabolite N-desmethyl-selumetinib in Adult Patients With Advanced Solid Tumors and Children With Low-Grade Gliomas.

Patel YT, Daryani VM, Patel P, Zhou D, Fangusaro J, Carlile DJ, Martin PD, Aarons L, Stewart CF.

CPT Pharmacometrics Syst Pharmacol. 2017 May;6(5):305-314. doi: 10.1002/psp4.12175. Epub 2017 Mar 22. Erratum in: CPT Pharmacometrics Syst Pharmacol. 2017 Oct;6(10 ):719.

6.

Pharmacokinetics and pharmacogenetics of the MEK1/2 inhibitor, selumetinib, in Asian and Western healthy subjects: a pooled analysis.

Dymond AW, Elks C, Martin P, Carlile DJ, Mariani G, Lovick S, Huang Y, Lorch U, Brown H, So K.

Eur J Clin Pharmacol. 2017 Jun;73(6):717-726. doi: 10.1007/s00228-017-2217-3. Epub 2017 Mar 10.

7.

Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma.

Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ.

Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.

8.

Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia.

Byrd JC, Flynn JM, Kipps TJ, Boxer M, Kolibaba KS, Carlile DJ, Fingerle-Rowson G, Tyson N, Hirata J, Sharman JP.

Blood. 2016 Jan 7;127(1):79-86. doi: 10.1182/blood-2015-03-634394. Epub 2015 Oct 15.

9.

Challenges and Opportunities for Quantitative Clinical Pharmacology in Cancer Immunotherapy: Something Old, Something New, Something Borrowed, and Something Blue.

Stroh M, Carlile DJ, Li CC, Wagg J, Ribba B, Ramanujan S, Jin J, Xu J, Charoin JE, Xhu ZX, Morcos PN, Davis JD, Phipps A.

CPT Pharmacometrics Syst Pharmacol. 2015 Sep;4(9):495-7. doi: 10.1002/psp4.12014. Epub 2015 Sep 11.

10.

Population Pharmacokinetics of Obinutuzumab (GA101) in Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma and Exposure-Response in CLL.

Gibiansky E, Gibiansky L, Carlile DJ, Jamois C, Buchheit V, Frey N.

CPT Pharmacometrics Syst Pharmacol. 2014 Oct 29;3:e144. doi: 10.1038/psp.2014.42.

11.

Effect of hepatic and renal impairment on the pharmacokinetics of dalcetrapib: altered distribution of the active thiol?

Phelan M, Anzures-Cabrera J, Carlile DJ, Rowell L, Kuhlmann O, Arold G, Robson R, Bentley D.

Clin Pharmacokinet. 2013 Apr;52(4):255-65. doi: 10.1007/s40262-013-0035-z.

PMID:
23400900
12.

A phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignancies.

Sehn LH, Assouline SE, Stewart DA, Mangel J, Gascoyne RD, Fine G, Frances-Lasserre S, Carlile DJ, Crump M.

Blood. 2012 May 31;119(22):5118-25. doi: 10.1182/blood-2012-02-408773. Epub 2012 Mar 20.

PMID:
22438256
13.

Scaling factors for the extrapolation of in vivo metabolic drug clearance from in vitro data: reaching a consensus on values of human microsomal protein and hepatocellularity per gram of liver.

Barter ZE, Bayliss MK, Beaune PH, Boobis AR, Carlile DJ, Edwards RJ, Houston JB, Lake BG, Lipscomb JC, Pelkonen OR, Tucker GT, Rostami-Hodjegan A.

Curr Drug Metab. 2007 Jan;8(1):33-45. Review.

PMID:
17266522
14.

Determination of a human hepatic microsomal scaling factor for predicting in vivo drug clearance.

Hakooz N, Ito K, Rawden H, Gill H, Lemmers L, Boobis AR, Edwards RJ, Carlile DJ, Lake BG, Houston JB.

Pharm Res. 2006 Mar;23(3):533-9. Epub 2006 Feb 28.

PMID:
16505976
15.

Microsomal prediction of in vivo clearance and associated interindividual variability of six benzodiazepines in humans.

Rawden HC, Carlile DJ, Tindall A, Hallifax D, Galetin A, Ito K, Houston JB.

Xenobiotica. 2005 Jun;35(6):603-25.

PMID:
16192111
16.

Comparative study of the metabolism of drug substrates by human cytochrome P450 3A4 expressed in bacterial, yeast and human lymphoblastoid cells.

Andrews J, Abd-Ellah MF, Randolph NL, Kenworthy KE, Carlile DJ, Friedberg T, Houston JB.

Xenobiotica. 2002 Nov;32(11):937-47.

PMID:
12487724
17.

Implications and consequences of enzyme induction on preclinical and clinical drug development.

Worboys PD, Carlile DJ.

Xenobiotica. 2001 Aug-Sep;31(8-9):539-56. Review.

PMID:
11569525
18.

Microsomal prediction of in vivo clearance of CYP2C9 substrates in humans.

Carlile DJ, Hakooz N, Bayliss MK, Houston JB.

Br J Clin Pharmacol. 1999 Jun;47(6):625-35.

20.
21.

Prediction of hepatic clearance from microsomes, hepatocytes, and liver slices.

Houston JB, Carlile DJ.

Drug Metab Rev. 1997 Nov;29(4):891-922. Review. No abstract available.

PMID:
9421679
22.

Incorporation of in vitro drug metabolism data into physiologically-based pharmacokinetic models.

Houston JB, Carlile DJ.

Toxicol In Vitro. 1997 Oct;11(5):473-8.

PMID:
20654337
24.
25.

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