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Items: 28


Performance of the SAEM and FOCEI Algorithms in the Open-Source, Nonlinear Mixed Effect Modeling Tool nlmixr.

Schoemaker R, Fidler M, Laveille C, Wilkins JJ, Hooijmaijers R, Post TM, Trame MN, Xiong Y, Wang W.

CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):923-930. doi: 10.1002/psp4.12471. Epub 2019 Nov 18.


Nonlinear Mixed-Effects Model Development and Simulation Using nlmixr and Related R Open-Source Packages.

Fidler M, Wilkins JJ, Hooijmaijers R, Post TM, Schoemaker R, Trame MN, Xiong Y, Wang W.

CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):621-633. doi: 10.1002/psp4.12445. Epub 2019 Jul 16.


Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study.

Kim S, Sharma VD, Lingineni K, Farhan N, Fang L, Zhao L, Brown JD, Cristofoletti R, Vozmediano V, Ait-Oudhia S, Lesko LJ, Trame MN, Schmidt S.

J Clin Pharmacol. 2019 Sep;59(9):1266-1274. doi: 10.1002/jcph.1433. Epub 2019 May 14.


Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products.

Basu S, Yang H, Fang L, Gonzalez-Sales M, Zhao L, Trame MN, Lesko L, Schmidt S.

J Clin Pharmacol. 2019 Sep;59(9):1252-1263. doi: 10.1002/jcph.1017. Epub 2019 May 14. Erratum in: J Clin Pharmacol. 2019 Sep;59(9):1264-1265.


An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction.

Lesko LJ, Fang L, Schmidt S, Trame MN.

J Clin Pharmacol. 2019 Sep;59(9):1245-1248. doi: 10.1002/jcph.901. Epub 2019 May 14. No abstract available.


Is Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations.

Kim H, Fang L, Yu J, Meng Z, Trame MN, Schmidt S, Lesko LJ, Zhao L.

J Clin Pharmacol. 2019 Aug;59(8):1061-1069. doi: 10.1002/jcph.1380. Epub 2019 Feb 4.


A pre-clinical quantitative model predicts the pharmacokinetics/pharmacodynamics of an anti-BDCA2 monoclonal antibody in humans.

Biliouris K, Nestorov I, Naik H, Dai D, Xiao G, Wang Q, Pellerin A, Rabah D, Lesko LJ, Trame MN.

J Pharmacokinet Pharmacodyn. 2018 Dec;45(6):817-827. doi: 10.1007/s10928-018-9609-6. Epub 2018 Oct 30.


A Semi-Mechanistic Population Pharmacokinetic Model of Nusinersen: An Antisense Oligonucleotide for the Treatment of Spinal Muscular Atrophy.

Biliouris K, Gaitonde P, Yin W, Norris DA, Wang Y, Henry S, Fey R, Nestorov I, Schmidt S, Rogge M, Lesko LJ, Trame MN.

CPT Pharmacometrics Syst Pharmacol. 2018 Sep;7(9):581-592. doi: 10.1002/psp4.12323. Epub 2018 Aug 16.


Perspective on the State of Pharmacometrics and Systems Pharmacology Integration.

Trame MN, Riggs M, Biliouris K, Marathe D, Mettetal J, Post TM, Rizk ML, Visser SAG, Musante CJ.

CPT Pharmacometrics Syst Pharmacol. 2018 Oct;7(10):617-620. doi: 10.1002/psp4.12313. Epub 2018 Aug 21. Review.


Model-Based Approach to Predict Adherence to Protocol During Antiobesity Trials.

Sharma VD, Combes FP, Vakilynejad M, Lahu G, Lesko LJ, Trame MN.

J Clin Pharmacol. 2018 Feb;58(2):240-253. doi: 10.1002/jcph.994. Epub 2017 Aug 31.


Development and validation of a LC-MS/MS assay for quantification of cisplatin in rat plasma and urine.

Shaik AN, Altomare DA, Lesko LJ, Trame MN.

J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Mar 1;1046:243-249. doi: 10.1016/j.jchromb.2016.11.027. Epub 2016 Nov 23.


Quantitative Systems Pharmacology Model to Predict the Effects of Commonly Used Anticoagulants on the Human Coagulation Network.

Hartmann S, Biliouris K, Lesko LJ, Nowak-Göttl U, Trame MN.

CPT Pharmacometrics Syst Pharmacol. 2016 Oct;5(10):554-564. doi: 10.1002/psp4.12111. Epub 2016 Sep 20.


The American Conference on Pharmacometrics 2016 (ACoP7).

Ouellet D, Trame MN, Corrigan B.

J Pharmacokinet Pharmacodyn. 2016 Oct;43(Suppl 1):1-2. No abstract available.


Systems pharmacology in drug development and therapeutic use - A forthcoming paradigm shift.

Kloft C, Trame MN, Ritter CA.

Eur J Pharm Sci. 2016 Oct 30;94:1-3. doi: 10.1016/j.ejps.2016.07.014. Epub 2016 Jul 21. No abstract available.


Improving drug safety with a systems pharmacology approach.

Schotland P, Bojunga N, Zien A, Trame MN, Lesko LJ.

Eur J Pharm Sci. 2016 Oct 30;94:84-92. doi: 10.1016/j.ejps.2016.06.009. Epub 2016 Jun 7.


Systems pharmacology to predict drug safety in drug development.

Trame MN, Biliouris K, Lesko LJ, Mettetal JT.

Eur J Pharm Sci. 2016 Oct 30;94:93-95. doi: 10.1016/j.ejps.2016.05.027. Epub 2016 May 29. Review.


A Comprehensive Review of Novel Drug-Disease Models in Diabetes Drug Development.

Gaitonde P, Garhyan P, Link C, Chien JY, Trame MN, Schmidt S.

Clin Pharmacokinet. 2016 Jul;55(7):769-788. doi: 10.1007/s40262-015-0359-y. Review.


MatVPC: A User-Friendly MATLAB-Based Tool for the Simulation and Evaluation of Systems Pharmacology Models.

Biliouris K, Lavielle M, Trame MN.

CPT Pharmacometrics Syst Pharmacol. 2015 Sep;4(9):547-57. doi: 10.1002/psp4.12011. Epub 2015 Aug 22.


Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds.

Somani AA, Thelen K, Zheng S, Trame MN, Coboeken K, Meyer M, Schnizler K, Ince I, Willmann S, Schmidt S.

Br J Clin Pharmacol. 2016 Jan;81(1):137-47. doi: 10.1111/bcp.12752. Epub 2015 Oct 30.


Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models.

Zhang XY, Trame MN, Lesko LJ, Schmidt S.

CPT Pharmacometrics Syst Pharmacol. 2015 Feb;4(2):69-79. doi: 10.1002/psp4.6.


Evaluation of effects of busulfan and DMA on SOS in pediatric stem cell recipients.

Kerl K, Diestelhorst C, Bartelink I, Boelens J, Trame MN, Boos J, Hempel G.

Pediatr Blood Cancer. 2014 Feb;61(2):306-11. doi: 10.1002/pbc.24827. Epub 2013 Oct 30.


Population pharmacokinetics of dimethylacetamide in children during standard and once-daily IV busulfan administration.

Trame MN, Bartelink IH, Boos J, Boelens JJ, Hempel G.

Cancer Chemother Pharmacol. 2013 Nov;72(5):1149-55. doi: 10.1007/s00280-013-2284-9. Epub 2013 Sep 15.


Population pharmacokinetics of escalating doses of caspofungin in a phase II study of patients with invasive aspergillosis.

Würthwein G, Cornely OA, Trame MN, Vehreschild JJ, Vehreschild MJ, Farowski F, Müller C, Boos J, Hempel G, Hallek M, Groll AH.

Antimicrob Agents Chemother. 2013 Apr;57(4):1664-71. doi: 10.1128/AAC.01912-12. Epub 2013 Jan 18.


Population pharmacokinetics of liposomal amphotericin B and caspofungin in allogeneic hematopoietic stem cell recipients.

Würthwein G, Young C, Lanvers-Kaminsky C, Hempel G, Trame MN, Schwerdtfeger R, Ostermann H, Heinz WJ, Cornely OA, Kolve H, Boos J, Silling G, Groll AH.

Antimicrob Agents Chemother. 2012 Jan;56(1):536-43. doi: 10.1128/AAC.00265-11. Epub 2011 Nov 14.


Population pharmacokinetics of busulfan in children: increased evidence for body surface area and allometric body weight dosing of busulfan in children.

Trame MN, Bergstrand M, Karlsson MO, Boos J, Hempel G.

Clin Cancer Res. 2011 Nov 1;17(21):6867-77. doi: 10.1158/1078-0432.CCR-11-0074. Epub 2011 Sep 14.


The management of hypertensive emergencies in children after stem cell transplantation.

Horn DG, Trame MN, Hempel G.

Int J Clin Pharm. 2011 Apr;33(2):165-76. doi: 10.1007/s11096-011-9495-0. Epub 2011 Mar 12. Review.


Therapeutic drug monitoring of busulfan.

Hempel G, Trame MN.

Clin Chem. 2011 Apr;57(4):643-4; author reply 644-5. doi: 10.1373/clinchem.2010.155374. Epub 2011 Feb 1. No abstract available.


Population pharmacokinetics of enoxaparin in infants, children and adolescents during secondary thromboembolic prophylaxis: a cohort study.

Trame MN, Mitchell L, Krümpel A, Male C, Hempel G, Nowak-Göttl U.

J Thromb Haemost. 2010 Sep;8(9):1950-8. doi: 10.1111/j.1538-7836.2010.03964.x.

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