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Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast.

Facius A, Krause A, Claret L, Bruno R, Lahu G.

J Clin Pharmacol. 2017 Apr 17. doi: 10.1002/jcph.885. [Epub ahead of print]


A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer.

Thomas M, Sadjadian P, Kollmeier J, Lowe J, Mattson P, Trout JR, Gargano M, Patchen ML, Walsh R, Beliveau M, Marier JF, Bose N, Gorden K, Schneller F 3rd.

Invest New Drugs. 2017 Jun;35(3):345-358. doi: 10.1007/s10637-017-0450-3. Epub 2017 Mar 16.


Phxnlme: An R package that facilitates pharmacometric workflow of Phoenix NLME analyses.

Lim CN, Liang S, Feng K, Chittenden J, Henry A, Mouksassi S, Birnbaum AK.

Comput Methods Programs Biomed. 2017 Mar;140:121-129. doi: 10.1016/j.cmpb.2016.12.002. Epub 2016 Dec 7.


The Clinical Pharmacokinetics and Pharmacodynamics of Atezolizumab in Metastatic Urothelial Carcinoma.

Stroh M, Winter H, Marchand M, Claret L, Eppler S, Ruppel J, Abidoye O, Teng SL, Lin WT, Dayog S, Bruno R, Jin J, Girish S.

Clin Pharmacol Ther. 2016 Dec 16. doi: 10.1002/cpt.587. [Epub ahead of print]


Population Pharmacokinetics and Exposure-Response Relationship of Carfilzomib in Patients With Multiple Myeloma.

Ou Y, Doshi S, Nguyen A, Jonsson F, Aggarwal S, Rajangam K, Dimopoulos MA, Stewart AK, Badros A, Papadopoulos KP, Siegel D, Jagannath S, Vij R, Niesvizky R, Graham R, Visich J.

J Clin Pharmacol. 2017 May;57(5):663-677. doi: 10.1002/jcph.850. Epub 2016 Dec 7.


An integrated pharmacokinetic/pharmacogenomic analysis of ABCB1 and SLCO1B1 polymorphisms on edoxaban exposure.

Vandell AG, Lee J, Shi M, Rubets I, Brown KS, Walker JR.

Pharmacogenomics J. 2016 Nov 29. doi: 10.1038/tpj.2016.82. [Epub ahead of print]


Pharmacokinetic profile of defibrotide in patients with renal impairment.

Tocchetti P, Tudone E, Marier JF, Marbury TC, Zomorodi K, Eller M.

Drug Des Devel Ther. 2016 Aug 16;10:2631-41. doi: 10.2147/DDDT.S112181. eCollection 2016.


Model-based prediction of progression-free survival in patients with first-line renal cell carcinoma using week 8 tumor size change from baseline.

Claret L, Zheng J, Mercier F, Chanu P, Chen Y, Rosbrook B, Yazdi P, Milligan PA, Bruno R.

Cancer Chemother Pharmacol. 2016 Sep;78(3):605-10. doi: 10.1007/s00280-016-3116-5. Epub 2016 Jul 28.


Simulations to Predict Clinical Trial Outcome of Bevacizumab Plus Chemotherapy vs. Chemotherapy Alone in Patients With First-Line Gastric Cancer and Elevated Plasma VEGF-A.

Han K, Claret L, Piao Y, Hegde P, Joshi A, Powell JR, Jin J, Bruno R.

CPT Pharmacometrics Syst Pharmacol. 2016 Jul;5(7):352-8. doi: 10.1002/psp4.12064. Epub 2016 Jul 12.


Population pharmacokinetics of bevacizumab in cancer patients with external validation.

Han K, Peyret T, Marchand M, Quartino A, Gosselin NH, Girish S, Allison DE, Jin J.

Cancer Chemother Pharmacol. 2016 Aug;78(2):341-51. doi: 10.1007/s00280-016-3079-6. Epub 2016 Jun 21.


Population pharmacokinetic modeling of motesanib and its active metabolite, M4, in cancer patients.

Gosselin NH, Mouksassi MS, Lu JF, Hsu CP.

Clin Pharmacol Drug Dev. 2015 Nov;4(6):463-72. doi: 10.1002/cpdd.196. Epub 2015 Jul 23.


A Tumor Growth Inhibition Model Based on M-Protein Levels in Subjects With Relapsed/Refractory Multiple Myeloma Following Single-Agent Carfilzomib Use.

Jonsson F, Ou Y, Claret L, Siegel D, Jagannath S, Vij R, Badros A, Aggarwal S, Bruno R.

CPT Pharmacometrics Syst Pharmacol. 2015 Dec;4(12):711-9. doi: 10.1002/psp4.12044. Epub 2015 Nov 20.


Antiphospholipid antibody-mediated effects in an arterial model of thrombosis are dependent on Toll-like receptor 4.

Laplante P, Fuentes R, Salem D, Subang R, Gillis MA, Hachem A, Farhat N, Qureshi ST, Fletcher CA, Roubey RA, Merhi Y, Thorin É, Levine JS, Mackman N, Rauch J.

Lupus. 2016 Feb;25(2):162-76. doi: 10.1177/0961203315603146. Epub 2015 Sep 21.


Population pharmacokinetics and dosing implications for cobimetinib in patients with solid tumors.

Han K, Jin JY, Marchand M, Eppler S, Choong N, Hack SP, Tikoo N, Bruno R, Dresser M, Musib L, Budha NR.

Cancer Chemother Pharmacol. 2015 Nov;76(5):917-24. doi: 10.1007/s00280-015-2862-0. Epub 2015 Sep 13.


Bevacizumab dosing strategy in paediatric cancer patients based on population pharmacokinetic analysis with external validation.

Han K, Peyret T, Quartino A, Gosselin NH, Gururangan S, Casanova M, Merks JH, Massimino M, Grill J, Daw NC, Navid F, Jin J, Allison DE.

Br J Clin Pharmacol. 2016 Jan;81(1):148-60. doi: 10.1111/bcp.12778. Epub 2015 Dec 10.


Modeling and simulations relating overall survival to tumor growth inhibition in renal cell carcinoma patients.

Claret L, Mercier F, Houk BE, Milligan PA, Bruno R.

Cancer Chemother Pharmacol. 2015 Sep;76(3):567-73. doi: 10.1007/s00280-015-2820-x. Epub 2015 Jul 22.


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.


Acute High-Intensity Intermittent Aerobic Exercise Reduces Plasma Angiopoietin-Like 2 in Patients With Coronary Artery Disease.

Larouche JF, Yu C, Luo X, Farhat N, Guiraud T, Lalongé J, Gayda M, Juneau M, Lambert J, Thorin-Trescases N, Thorin E, Nigam A.

Can J Cardiol. 2015 Oct;31(10):1232-9. doi: 10.1016/j.cjca.2015.01.038. Epub 2015 Feb 4.


Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal implant for HIV prophylaxis.

Gunawardana M, Remedios-Chan M, Miller CS, Fanter R, Yang F, Marzinke MA, Hendrix CW, Beliveau M, Moss JA, Smith TJ, Baum MM.

Antimicrob Agents Chemother. 2015 Jul;59(7):3913-9. doi: 10.1128/AAC.00656-15. Epub 2015 Apr 20.

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