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Open Systems Pharmacology Community-An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences.

Lippert J, Burghaus R, Edginton A, Frechen S, Karlsson M, Kovar A, Lehr T, Milligan P, Nock V, Ramusovic S, Riggs M, Schaller S, Schlender J, Schmidt S, Sevestre M, Sjögren E, Solodenko J, Staab A, Teutonico D.

CPT Pharmacometrics Syst Pharmacol. 2019 Oct 31. doi: 10.1002/psp4.12473. [Epub ahead of print] Review. No abstract available.


Physiologically Based Pharmacokinetic Models for Prediction of Complex CYP2C8 and OATP1B1 (SLCO1B1) Drug-Drug-Gene Interactions: A Modeling Network of Gemfibrozil, Repaglinide, Pioglitazone, Rifampicin, Clarithromycin and Itraconazole.

Türk D, Hanke N, Wolf S, Frechen S, Eissing T, Wendl T, Schwab M, Lehr T.

Clin Pharmacokinet. 2019 May 25. doi: 10.1007/s40262-019-00777-x. [Epub ahead of print]


A Comprehensive Whole-Body Physiologically Based Pharmacokinetic Model of Dabigatran Etexilate, Dabigatran and Dabigatran Glucuronide in Healthy Adults and Renally Impaired Patients.

Moj D, Maas H, Schaeftlein A, Hanke N, Gómez-Mantilla JD, Lehr T.

Clin Pharmacokinet. 2019 May 18. doi: 10.1007/s40262-019-00776-y. [Epub ahead of print]


Translational PBPK Modeling of the Protein Therapeutic and CD95L Inhibitor Asunercept to Develop Dose Recommendations for Its First Use in Pediatric Glioblastoma Patients.

Hanke N, Kunz C, Thiemann M, Fricke H, Lehr T.

Pharmaceutics. 2019 Apr 1;11(4). pii: E152. doi: 10.3390/pharmaceutics11040152.


Physiologically-Based Pharmacokinetic Models for CYP1A2 Drug-Drug Interaction Prediction: A Modeling Network of Fluvoxamine, Theophylline, Caffeine, Rifampicin, and Midazolam.

Britz H, Hanke N, Volz AK, Spigset O, Schwab M, Eissing T, Wendl T, Frechen S, Lehr T.

CPT Pharmacometrics Syst Pharmacol. 2019 May;8(5):296-307. doi: 10.1002/psp4.12397. Epub 2019 Mar 13.


Population Pharmacokinetics of Mefloquine Intermittent Preventive Treatment for Malaria in Pregnancy in Gabon.

Ramharter M, Schwab M, Mombo-Ngoma G, Zoleko Manego R, Akerey-Diop D, Basra A, Mackanga JR, Würbel H, Wojtyniak JG, Gonzalez R, Hofmann U, Geditz M, Matsiegui PB, Kremsner PG, Menendez C, Kerb R, Lehr T.

Antimicrob Agents Chemother. 2019 Jan 29;63(2). pii: e01113-18. doi: 10.1128/AAC.01113-18. Print 2019 Feb.


A Quantitative Systems Pharmacology Kidney Model of Diabetes Associated Renal Hyperfiltration and the Effects of SGLT Inhibitors.

Balazki P, Schaller S, Eissing T, Lehr T.

CPT Pharmacometrics Syst Pharmacol. 2018 Dec;7(12):788-797. doi: 10.1002/psp4.12359. Epub 2018 Oct 22.


PBPK Models for CYP3A4 and P-gp DDI Prediction: A Modeling Network of Rifampicin, Itraconazole, Clarithromycin, Midazolam, Alfentanil, and Digoxin.

Hanke N, Frechen S, Moj D, Britz H, Eissing T, Wendl T, Lehr T.

CPT Pharmacometrics Syst Pharmacol. 2018 Oct;7(10):647-659. doi: 10.1002/psp4.12343. Epub 2018 Sep 7.


Can toxicokinetics of (synthetic) cannabinoids in pigs after pulmonary administration be upscaled to humans by allometric techniques?

Schaefer N, Wojtyniak JG, Kroell AK, Koerbel C, Laschke MW, Lehr T, Menger MD, Maurer HH, Meyer MR, Schmidt PH.

Biochem Pharmacol. 2018 Sep;155:403-418. doi: 10.1016/j.bcp.2018.07.029. Epub 2018 Jul 24.


Neovascular Age-Related Macular Degeneration: A Visual Acuity Model of Natural Disease Progression and Ranibizumab Treatment Effect.

Mulyukov Z, Weber S, Pigeolet E, Clemens A, Lehr T, Racine A.

CPT Pharmacometrics Syst Pharmacol. 2018 Oct;7(10):660-669. doi: 10.1002/psp4.12322. Epub 2018 Aug 15.


Inhibition of Cyclin-Dependent Kinase 5: A Strategy to Improve Sorafenib Response in Hepatocellular Carcinoma Therapy.

Ardelt MA, Fröhlich T, Martini E, Müller M, Kanitz V, Atzberger C, Cantonati P, Meßner M, Posselt L, Lehr T, Wojtyniak JG, Ulrich M, Arnold GJ, König L, Parazzoli D, Zahler S, Rothenfußer S, Mayr D, Gerbes A, Scita G, Vollmar AM, Pachmayr J.

Hepatology. 2019 Jan;69(1):376-393. doi: 10.1002/hep.30190. Epub 2018 Dec 22.


XplOit: An Ontology-Based Data Integration Platform Supporting the Development of Predictive Models for Personalized Medicine.

Weiler G, Schwarz U, Rauch J, Rohm K, Lehr T, Theobald S, Kiefer S, Götz K, Och K, Pfeifer N, Handl L, Smola S, Ihle M, Turki AT, Beelen DW, Rissland J, Bittenbring J, Graf N.

Stud Health Technol Inform. 2018;247:21-25.


Population nutrikinetics of green tea extract.

Scholl C, Lepper A, Lehr T, Hanke N, Schneider KL, Brockmöller J, Seufferlein T, Stingl JC.

PLoS One. 2018 Feb 21;13(2):e0193074. doi: 10.1371/journal.pone.0193074. eCollection 2018.


How to disentangle psychobiological stress reactivity and recovery: A comparison of model-based and non-compartmental analyses of cortisol concentrations.

Miller R, Wojtyniak JG, Weckesser LJ, Alexander NC, Engert V, Lehr T.

Psychoneuroendocrinology. 2018 Apr;90:194-210. doi: 10.1016/j.psyneuen.2017.12.019. Epub 2017 Dec 29.


A physiologically based pharmacokinetic (PBPK) parent-metabolite model of the chemotherapeutic zoptarelin doxorubicin-integration of in vitro results, Phase I and Phase II data and model application for drug-drug interaction potential analysis.

Hanke N, Teifel M, Moj D, Wojtyniak JG, Britz H, Aicher B, Sindermann H, Ammer N, Lehr T.

Cancer Chemother Pharmacol. 2018 Feb;81(2):291-304. doi: 10.1007/s00280-017-3495-2. Epub 2017 Dec 4.


The feasibility of physiologically based pharmacokinetic modeling in forensic medicine illustrated by the example of morphine.

Schaefer N, Moj D, Lehr T, Schmidt PH, Ramsthaler F.

Int J Legal Med. 2018 Mar;132(2):415-424. doi: 10.1007/s00414-017-1754-8. Epub 2017 Dec 1.


A physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) model of the histone deacetylase (HDAC) inhibitor vorinostat for pediatric and adult patients and its application for dose specification.

Moj D, Britz H, Burhenne J, Stewart CF, Egerer G, Haefeli WE, Lehr T.

Cancer Chemother Pharmacol. 2017 Nov;80(5):1013-1026. doi: 10.1007/s00280-017-3447-x. Epub 2017 Oct 7.


Modeling Tolerance Development for the Effect on Heart Rate of the Selective S1P1 Receptor Modulator Ponesimod.

Lott D, Lehr T, Dingemanse J, Krause A.

Clin Pharmacol Ther. 2018 Jun;103(6):1083-1092. doi: 10.1002/cpt.877. Epub 2017 Oct 27.


Target-Mediated Drug Disposition Pharmacokinetic-Pharmacodynamic Model of Bosentan and Endothelin-1.

Volz AK, Krause A, Haefeli WE, Dingemanse J, Lehr T.

Clin Pharmacokinet. 2017 Dec;56(12):1499-1511. doi: 10.1007/s40262-017-0534-4.


Alternative Treatment Regimens With the PCSK9 Inhibitors Alirocumab and Evolocumab: A Pharmacokinetic and Pharmacodynamic Modeling Approach.

Scherer N, Dings C, Böhm M, Laufs U, Lehr T.

J Clin Pharmacol. 2017 Jul;57(7):846-854. doi: 10.1002/jcph.866. Epub 2017 Mar 6.


An allometric pharmacokinetic/pharmacodynamics model for BI 893923, a novel IGF-1 receptor inhibitor.

Titze MI, Schaaf O, Hofmann MH, Sanderson MP, Zahn SK, Quant J, Lehr T.

Cancer Chemother Pharmacol. 2017 Mar;79(3):545-558. doi: 10.1007/s00280-017-3252-6. Epub 2017 Feb 27.


Modeling the Effect of the Selective S1P1 Receptor Modulator Ponesimod on Subsets of Blood Lymphocytes.

Lott D, Krause A, Seemayer CA, Strasser DS, Dingemanse J, Lehr T.

Pharm Res. 2017 Mar;34(3):599-609. doi: 10.1007/s11095-016-2087-x. Epub 2016 Dec 27.


A generic viral dynamic model to systematically characterize the interaction between oncolytic virus kinetics and tumor growth.

Titze MI, Frank J, Ehrhardt M, Smola S, Graf N, Lehr T.

Eur J Pharm Sci. 2017 Jan 15;97:38-46. doi: 10.1016/j.ejps.2016.11.003. Epub 2016 Nov 5.


Clarithromycin, Midazolam, and Digoxin: Application of PBPK Modeling to Gain New Insights into Drug-Drug Interactions and Co-medication Regimens.

Moj D, Hanke N, Britz H, Frechen S, Kanacher T, Wendl T, Haefeli WE, Lehr T.

AAPS J. 2017 Jan;19(1):298-312. doi: 10.1208/s12248-016-0009-9. Epub 2016 Nov 7.


Impact of Demographics, Organ Impairment, Disease, Formulation, and Food on the Pharmacokinetics of the Selective S1P1 Receptor Modulator Ponesimod Based on 13 Clinical Studies.

Lott D, Lehr T, Dingemanse J, Krause A.

Clin Pharmacokinet. 2017 Apr;56(4):395-408. doi: 10.1007/s40262-016-0446-8.


Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents. An open-label phase IIa study.

Halton JM, Lehr T, Cronin L, Lobmeyer MT, Haertter S, Belletrutti M, Mitchell LG.

Thromb Haemost. 2016 Aug 30;116(3):461-71. doi: 10.1160/TH15-04-0275. Epub 2016 Jun 30.


A comprehensive pharmacokinetic/pharmacodynamics analysis of the novel IGF1R/INSR inhibitor BI 893923 applying in vitro, in vivo and in silico modeling techniques.

Titze MI, Schaaf O, Hofmann MH, Sanderson MP, Zahn SK, Quant J, Lehr T.

Cancer Chemother Pharmacol. 2016 Jun;77(6):1303-14. doi: 10.1007/s00280-016-3049-z. Epub 2016 May 9.


MDM2 antagonist nutlin-3a sensitizes tumors to V-ATPase inhibition.

Schneider LS, Ulrich M, Lehr T, Menche D, Müller R, von Schwarzenberg K.

Mol Oncol. 2016 Aug;10(7):1054-62. doi: 10.1016/j.molonc.2016.04.005. Epub 2016 Apr 27.


First-in-human application of the novel hepatitis B and hepatitis D virus entry inhibitor myrcludex B.

Blank A, Markert C, Hohmann N, Carls A, Mikus G, Lehr T, Alexandrov A, Haag M, Schwab M, Urban S, Haefeli WE.

J Hepatol. 2016 Sep;65(3):483-9. doi: 10.1016/j.jhep.2016.04.013. Epub 2016 Apr 27.


Treatment of chronic hepatitis D with the entry inhibitor myrcludex B: First results of a phase Ib/IIa study.

Bogomolov P, Alexandrov A, Voronkova N, Macievich M, Kokina K, Petrachenkova M, Lehr T, Lempp FA, Wedemeyer H, Haag M, Schwab M, Haefeli WE, Blank A, Urban S.

J Hepatol. 2016 Sep;65(3):490-8. doi: 10.1016/j.jhep.2016.04.016. Epub 2016 Apr 27.


Pharmacokinetics of (synthetic) cannabinoids in pigs and their relevance for clinical and forensic toxicology.

Schaefer N, Wojtyniak JG, Kettner M, Schlote J, Laschke MW, Ewald AH, Lehr T, Menger MD, Maurer HH, Schmidt PH.

Toxicol Lett. 2016 Jun 24;253:7-16. doi: 10.1016/j.toxlet.2016.04.021. Epub 2016 Apr 23.


Population pharmacokinetics of ponesimod and its primary metabolites in healthy and organ-impaired subjects.

Lott D, Krause A, Dingemanse J, Lehr T.

Eur J Pharm Sci. 2016 Jun 30;89:83-93. doi: 10.1016/j.ejps.2016.04.021. Epub 2016 Apr 22.


Inhibition of endothelial Cdk5 reduces tumor growth by promoting non-productive angiogenesis.

Merk H, Zhang S, Lehr T, Müller C, Ulrich M, Bibb JA, Adams RH, Bracher F, Zahler S, Vollmar AM, Liebl J.

Oncotarget. 2016 Feb 2;7(5):6088-104. doi: 10.18632/oncotarget.6842.


Vacuolar-ATPase Inhibition Blocks Iron Metabolism to Mediate Therapeutic Effects in Breast Cancer.

Schneider LS, von Schwarzenberg K, Lehr T, Ulrich M, Kubisch-Dohmen R, Liebl J, Trauner D, Menche D, Vollmar AM.

Cancer Res. 2015 Jul 15;75(14):2863-74. doi: 10.1158/0008-5472.CAN-14-2097. Epub 2015 May 27.


Targeting cyclin dependent kinase 5 in hepatocellular carcinoma--A novel therapeutic approach.

Ehrlich SM, Liebl J, Ardelt MA, Lehr T, De Toni EN, Mayr D, Brandl L, Kirchner T, Zahler S, Gerbes AL, Vollmar AM.

J Hepatol. 2015 Jul;63(1):102-13. doi: 10.1016/j.jhep.2015.01.031. Epub 2015 Feb 7.


Statistical comparison of dissolution profiles to predict the bioequivalence of extended release formulations.

Gomez-Mantilla JD, Schaefer UF, Casabo VG, Lehr T, Lehr CM.

AAPS J. 2014 Jul;16(4):791-801. doi: 10.1208/s12248-014-9615-6. Epub 2014 May 23.


The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy).

Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, Ezekowitz MD, Nehmiz G, Wang S, Wallentin L; RE-LY Investigators.

J Am Coll Cardiol. 2014 Feb 4;63(4):321-8. doi: 10.1016/j.jacc.2013.07.104. Epub 2013 Sep 27.


A semi-physiological model of amyloid-β biosynthesis and clearance in human cerebrospinal fluid: a tool for alzheimer's disease research and drug development.

Haug KG, Staab A, Dansirikul C, Lehr T.

J Clin Pharmacol. 2013 Jul;53(7):691-8. doi: 10.1002/jcph.91. Epub 2013 May 27.


Pharmacometric characterization of dabigatran hemodialysis.

Liesenfeld KH, Staab A, Härtter S, Formella S, Clemens A, Lehr T.

Clin Pharmacokinet. 2013 Jun;52(6):453-62. doi: 10.1007/s40262-013-0049-6.


Genetic determinants of dabigatran plasma levels and their relation to bleeding.

Paré G, Eriksson N, Lehr T, Connolly S, Eikelboom J, Ezekowitz MD, Axelsson T, Haertter S, Oldgren J, Reilly P, Siegbahn A, Syvanen AC, Wadelius C, Wadelius M, Zimdahl-Gelling H, Yusuf S, Wallentin L.

Circulation. 2013 Apr 2;127(13):1404-12. doi: 10.1161/CIRCULATIONAHA.112.001233. Epub 2013 Mar 6.


Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal disease.

Khadzhynov D, Wagner F, Formella S, Wiegert E, Moschetti V, Slowinski T, Neumayer HH, Liesenfeld KH, Lehr T, Härtter S, Friedman J, Peters H, Clemens A.

Thromb Haemost. 2013 Apr;109(4):596-605. doi: 10.1160/TH12-08-0573. Epub 2013 Feb 7.


A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: THE Randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN).

Van de Werf F, Brueckmann M, Connolly SJ, Friedman J, Granger CB, Härtter S, Harper R, Kappetein AP, Lehr T, Mack MJ, Noack H, Eikelboom JW.

Am Heart J. 2012 Jun;163(6):931-937.e1. doi: 10.1016/j.ahj.2012.03.011.


A combined pharmacometric analysis of dabigatran etexilate in healthy volunteers and patients with atrial fibrillation or undergoing orthopaedic surgery.

Dansirikul C, Lehr T, Liesenfeld KH, Haertter S, Staab A.

Thromb Haemost. 2012 Apr;107(4):775-85. doi: 10.1160/TH11-09-0656. Epub 2012 Mar 8.


Twice daily dosing of dabigatran for stroke prevention in atrial fibrillation: a pharmacokinetic justification.

Clemens A, Haertter S, Friedman J, Brueckmann M, Stangier J, van Ryn J, Lehr T.

Curr Med Res Opin. 2012 Feb;28(2):195-201. doi: 10.1185/03007995.2011.654109. Epub 2012 Jan 23.


Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial.

Liesenfeld KH, Lehr T, Dansirikul C, Reilly PA, Connolly SJ, Ezekowitz MD, Yusuf S, Wallentin L, Haertter S, Staab A.

J Thromb Haemost. 2011 Nov;9(11):2168-75. doi: 10.1111/j.1538-7836.2011.04498.x.


Dabigatran etexilate in atrial fibrillation patients with severe renal impairment: dose identification using pharmacokinetic modeling and simulation.

Lehr T, Haertter S, Liesenfeld KH, Staab A, Clemens A, Reilly PA, Friedman J.

J Clin Pharmacol. 2012 Sep;52(9):1373-8. doi: 10.1177/0091270011417716. Epub 2011 Sep 28.


Integration of absorption, distribution, metabolism, and elimination genotyping data into a population pharmacokinetic analysis of nevirapine.

Lehr T, Yuan J, Hall D, Zimdahl-Gelling H, Schaefer HG, Staab A, MacGregor TR, Jayadev S.

Pharmacogenet Genomics. 2011 Nov;21(11):721-30. doi: 10.1097/FPC.0b013e32834a522e.


Rule based classifier for the analysis of gene-gene and gene-environment interactions in genetic association studies.

Lehr T, Yuan J, Zeumer D, Jayadev S, Ritchie MD.

BioData Min. 2011 Mar 1;4:4. doi: 10.1186/1756-0381-4-4.


N-Glycosylation patterns of hemolymph glycoproteins from Biomphalaria glabrata strains expressing different susceptibility to Schistosoma mansoni infection.

Lehr T, Frank S, Natsuka S, Geyer H, Beuerlein K, Doenhoff MJ, Hase S, Geyer R.

Exp Parasitol. 2010 Dec;126(4):592-602. doi: 10.1016/j.exppara.2010.06.031. Epub 2010 Jul 1.


Integration of high-throughput genotyping data into pharmacometric analyses using nonlinear mixed effects modeling.

Lehr T, Schaefer HG, Staab A.

Pharmacogenet Genomics. 2010 Jul;20(7):442-50.


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