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Model-Based Relationship between the Molecular Bacterial Load Assay and Time to Positivity in Liquid Culture.

Svensson RJ, Sabiiti W, Kibiki GS, Ntinginya NE, Bhatt N, Davies G, Gillespie SH, Simonsson USH.

Antimicrob Agents Chemother. 2019 Sep 23;63(10). pii: e00652-19. doi: 10.1128/AAC.00652-19. Print 2019 Oct.


Individualised dosing algorithm and personalised treatment of high-dose rifampicin for tuberculosis.

Svensson RJ, Niward K, Davies Forsman L, Bruchfeld J, Paues J, Eliasson E, Schön T, Simonsson USH.

Br J Clin Pharmacol. 2019 Oct;85(10):2341-2350. doi: 10.1111/bcp.14048. Epub 2019 Jul 25.


Plasma concentrations of second-line antituberculosis drugs in relation to minimum inhibitory concentrations in multidrug-resistant tuberculosis patients in China: a study protocol of a prospective observational cohort study.

Davies Forsman L, Niward K, Hu Y, Zheng R, Zheng X, Ke R, Cai W, Hong C, Li Y, Gao Y, Werngren J, Paues J, Kuhlin J, Simonsson USH, Eliasson E, Alffenaar JW, Mansjö M, Hoffner S, Xu B, Schön T, Bruchfeld J.

BMJ Open. 2018 Oct 4;8(9):e023899. doi: 10.1136/bmjopen-2018-023899.


Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs: a prospective cohort study in a low endemic setting.

Niward K, Davies Forsman L, Bruchfeld J, Chryssanthou E, Carlström O, Alomari T, Carlsson B, Pohanka A, Mansjö M, Jonsson Nordvall M, Johansson AG, Eliasson E, Werngren J, Paues J, Simonsson USH, Schön T.

J Antimicrob Chemother. 2018 Oct 1;73(10):2838-2845. doi: 10.1093/jac/dky268.


Impact of trial design on the estimation of drug potency and power in clinical trials of haemophilia with inhibitors.

Larsen MS, Juul RV, Kreilgaard M, Kristensen AT, Simonsson USH.

Eur J Pharm Sci. 2018 Oct 15;123:531-538. doi: 10.1016/j.ejps.2018.07.056. Epub 2018 Aug 3.


Comparisons of Analysis Methods for Assessment of Pharmacodynamic Interactions Including Design Recommendations.

Chen C, Wicha SG, Nordgren R, Simonsson USH.

AAPS J. 2018 Jun 21;20(4):77. doi: 10.1208/s12248-018-0239-0.


The Potential for Treatment Shortening With Higher Rifampicin Doses: Relating Drug Exposure to Treatment Response in Patients With Pulmonary Tuberculosis.

Svensson EM, Svensson RJ, Te Brake LHM, Boeree MJ, Heinrich N, Konsten S, Churchyard G, Dawson R, Diacon AH, Kibiki GS, Minja LT, Ntingiya NE, Sanne I, Gillespie SH, Hoelscher M, Phillips PPJ, Simonsson USH, Aarnoutse R.

Clin Infect Dis. 2018 Jun 18;67(1):34-41. doi: 10.1093/cid/ciy026.


Greater Early Bactericidal Activity at Higher Rifampicin Doses Revealed by Modeling and Clinical Trial Simulations.

Svensson RJ, Svensson EM, Aarnoutse RE, Diacon AH, Dawson R, Gillespie SH, Moodley M, Boeree MJ, Simonsson USH.

J Infect Dis. 2018 Aug 14;218(6):991-999. doi: 10.1093/infdis/jiy242.


Forecasting Clinical Dose-Response From Preclinical Studies in Tuberculosis Research: Translational Predictions With Rifampicin.

Wicha SG, Clewe O, Svensson RJ, Gillespie SH, Hu Y, Coates ARM, Simonsson USH.

Clin Pharmacol Ther. 2018 Dec;104(6):1208-1218. doi: 10.1002/cpt.1102. Epub 2018 Jun 19.


Improving treatment outcome assessment in a mouse tuberculosis model.

Mourik BC, Svensson RJ, de Knegt GJ, Bax HI, Verbon A, Simonsson USH, de Steenwinkel JEM.

Sci Rep. 2018 Apr 9;8(1):5714. doi: 10.1038/s41598-018-24067-x.


Prediction of human pharmacokinetics of activated recombinant factor VII and B-domain truncated factor VIII from animal population pharmacokinetic models of haemophilia.

Larsen MS, Juul RV, Groth AV, Simonsson USH, Kristensen AT, Knudsen T, Agersø H, Kreilgaard M.

Eur J Pharm Sci. 2018 Mar 30;115:196-203. doi: 10.1016/j.ejps.2018.01.035. Epub 2018 Jan 31.


A general pharmacodynamic interaction model identifies perpetrators and victims in drug interactions.

Wicha SG, Chen C, Clewe O, Simonsson USH.

Nat Commun. 2017 Dec 14;8(1):2129. doi: 10.1038/s41467-017-01929-y.


A model-informed preclinical approach for prediction of clinical pharmacodynamic interactions of anti-TB drug combinations.

Clewe O, Wicha SG, de Vogel CP, de Steenwinkel JEM, Simonsson USH.

J Antimicrob Chemother. 2018 Feb 1;73(2):437-447. doi: 10.1093/jac/dkx380.


Assessing Pharmacodynamic Interactions in Mice Using the Multistate Tuberculosis Pharmacometric and General Pharmacodynamic Interaction Models.

Chen C, Wicha SG, de Knegt GJ, Ortega F, Alameda L, Sousa V, de Steenwinkel JEM, Simonsson USH.

CPT Pharmacometrics Syst Pharmacol. 2017 Nov;6(11):787-797. doi: 10.1002/psp4.12226. Epub 2017 Oct 10.


A Population Pharmacokinetic Model Incorporating Saturable Pharmacokinetics and Autoinduction for High Rifampicin Doses.

Svensson RJ, Aarnoutse RE, Diacon AH, Dawson R, Gillespie SH, Boeree MJ, Simonsson USH.

Clin Pharmacol Ther. 2018 Apr;103(4):674-683. doi: 10.1002/cpt.778. Epub 2017 Aug 7.


Improved power for TB Phase IIa trials using a model-based pharmacokinetic-pharmacodynamic approach compared with commonly used analysis methods.

Svensson RJ, Gillespie SH, Simonsson USH.

J Antimicrob Chemother. 2017 Aug 1;72(8):2311-2319. doi: 10.1093/jac/dkx129.


Analysis of opioid consumption in clinical trials: a simulation based analysis of power of four approaches.

Juul RV, Nyberg J, Kreilgaard M, Christrup LL, Simonsson USH, Lund TM.

J Pharmacokinet Pharmacodyn. 2017 Aug;44(4):325-333. doi: 10.1007/s10928-017-9522-4. Epub 2017 Apr 7.


Residual Spinal Cord Compression Following Hemilaminectomy and Mini-Hemilaminectomy in Dogs: A Prospective Randomized Study.

Svensson G, Simonsson US, Danielsson F, Schwarz T.

Front Vet Sci. 2017 Mar 23;4:42. doi: 10.3389/fvets.2017.00042. eCollection 2017.


The multistate tuberculosis pharmacometric model: a semi-mechanistic pharmacokinetic-pharmacodynamic model for studying drug effects in an acute tuberculosis mouse model.

Chen C, Ortega F, Rullas J, Alameda L, Angulo-Barturen I, Ferrer S, Simonsson US.

J Pharmacokinet Pharmacodyn. 2017 Apr;44(2):133-141. doi: 10.1007/s10928-017-9508-2. Epub 2017 Feb 15.


The implications of model-informed drug discovery and development for tuberculosis.

Muliaditan M, Davies GR, Simonsson USH, Gillespie SH, Della Pasqua O.

Drug Discov Today. 2017 Mar;22(3):481-486. doi: 10.1016/j.drudis.2016.09.004. Epub 2016 Sep 28.


Population pharmacokinetics, optimised design and sample size determination for rifampicin, isoniazid, ethambutol and pyrazinamide in the mouse.

Chen C, Ortega F, Alameda L, Ferrer S, Simonsson US.

Eur J Pharm Sci. 2016 Oct 10;93:319-33. doi: 10.1016/j.ejps.2016.07.017. Epub 2016 Jul 26.


Population Pharmacokinetics of Edoxaban in Patients with Non-Valvular Atrial Fibrillation in the ENGAGE AF-TIMI 48 Study, a Phase III Clinical Trial.

Krekels EH, Niebecker R, Karlsson MO, Miller R, Shimizu T, Karlsson KE, Ruff CT, Simonsson US, Jönsson S.

Clin Pharmacokinet. 2016 Sep;55(9):1079-90. doi: 10.1007/s40262-016-0378-3.


A Pharmacokinetic-Pharmacodynamic Model of Morphine Exposure and Subsequent Morphine Consumption in Postoperative Pain.

Juul RV, Nyberg J, Lund TM, Rasmussen S, Kreilgaard M, Christrup LL, Simonsson US.

Pharm Res. 2016 May;33(5):1093-103. doi: 10.1007/s11095-015-1853-5. Epub 2016 Jan 11.


A multistate tuberculosis pharmacometric model: a framework for studying anti-tubercular drug effects in vitro.

Clewe O, Aulin L, Hu Y, Coates AR, Simonsson US.

J Antimicrob Chemother. 2016 Apr;71(4):964-74. doi: 10.1093/jac/dkv416. Epub 2015 Dec 24.


Repeated Time-to-event Analysis of Consecutive Analgesic Events in Postoperative Pain.

Juul RV, Rasmussen S, Kreilgaard M, Christrup LL, Simonsson US, Lund TM.

Anesthesiology. 2015 Dec;123(6):1411-9. doi: 10.1097/ALN.0000000000000917.


Evaluation of optimized bronchoalveolar lavage sampling designs for characterization of pulmonary drug distribution.

Clewe O, Karlsson MO, Simonsson US.

J Pharmacokinet Pharmacodyn. 2015 Dec;42(6):699-708. doi: 10.1007/s10928-015-9438-9. Epub 2015 Aug 28.


Population pharmacokinetics of edoxaban in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism--the Hokusai-VTE phase 3 study.

Niebecker R, Jönsson S, Karlsson MO, Miller R, Nyberg J, Krekels EH, Simonsson US.

Br J Clin Pharmacol. 2015 Dec;80(6):1374-87. doi: 10.1111/bcp.12727. Epub 2015 Sep 30.


A Recirculatory Model for Pharmacokinetics and the Effects on Bispectral Index After Intravenous Infusion of the Sedative and Anesthetic AZD3043 in Healthy Volunteers.

Björnsson MA, Norberg Å, Kalman S, Simonsson US.

Anesth Analg. 2015 Oct;121(4):904-13. doi: 10.1213/ANE.0000000000000814.


Population pharmacokinetics of edoxaban and its main metabolite in a dedicated renal impairment study.

Jönsson S, Simonsson US, Miller R, Karlsson MO.

J Clin Pharmacol. 2015 Nov;55(11):1268-79. doi: 10.1002/jcph.541. Epub 2015 Jun 30.


A pharmacometric pulmonary model predicting the extent and rate of distribution from plasma to epithelial lining fluid and alveolar cells--using rifampicin as an example.

Clewe O, Goutelle S, Conte JE Jr, Simonsson US.

Eur J Clin Pharmacol. 2015 Mar;71(3):313-9. doi: 10.1007/s00228-014-1798-3. Epub 2015 Jan 27.


Population pharmacokinetics of morphine and morphine-6-glucuronide following rectal administration--a dose escalation study.

Brokjær A, Kreilgaard M, Olesen AE, Simonsson US, Christrup LL, Dahan A, Drewes AM.

Eur J Pharm Sci. 2015 Feb 20;68:78-86. doi: 10.1016/j.ejps.2014.12.004. Epub 2014 Dec 5.


Performance of nonlinear mixed effects models in the presence of informative dropout.

Björnsson MA, Friberg LE, Simonsson US.

AAPS J. 2015 Jan;17(1):245-55. doi: 10.1208/s12248-014-9700-x. Epub 2014 Nov 25.


Intra- and extracellular activities of trimethoprim-sulfamethoxazole against susceptible and multidrug-resistant Mycobacterium tuberculosis.

Davies Forsman L, Schön T, Simonsson US, Bruchfeld J, Larsson M, Juréen P, Sturegård E, Giske CG, Ängeby K.

Antimicrob Agents Chemother. 2014 Dec;58(12):7557-9. doi: 10.1128/AAC.02995-14. Epub 2014 Sep 22.


Population pharmacokinetics of rifampicin, pyrazinamide and isoniazid in children with tuberculosis: in silico evaluation of currently recommended doses.

Zvada SP, Denti P, Donald PR, Schaaf HS, Thee S, Seddon JA, Seifart HI, Smith PJ, McIlleron HM, Simonsson US.

J Antimicrob Chemother. 2014 May;69(5):1339-49. doi: 10.1093/jac/dkt524. Epub 2014 Jan 31.


Moxifloxacin population pharmacokinetics and model-based comparison of efficacy between moxifloxacin and ofloxacin in African patients.

Zvada SP, Denti P, Sirgel FA, Chigutsa E, Hatherill M, Charalambous S, Mungofa S, Wiesner L, Simonsson US, Jindani A, Harrison T, McIlleron HM.

Antimicrob Agents Chemother. 2014;58(1):503-10. doi: 10.1128/AAC.01478-13. Epub 2013 Nov 4.


Model based design and analysis of phase II HIV-1 trials.

Rekić D, Röshammar D, Simonsson US.

J Pharmacokinet Pharmacodyn. 2013 Aug;40(4):487-96. doi: 10.1007/s10928-013-9324-2. Epub 2013 Jul 11.


Evaluation of initial and steady-state gatifloxacin pharmacokinetics and dose in pulmonary tuberculosis patients by using monte carlo simulations.

Smythe W, Merle CS, Rustomjee R, Gninafon M, Lo MB, Bah-Sow O, Olliaro PL, Lienhardt C, Horton J, Smith P, McIlleron H, Simonsson US.

Antimicrob Agents Chemother. 2013 Sep;57(9):4164-71. doi: 10.1128/AAC.00479-13. Epub 2013 Jun 17.


D optimal designs for three Poisson dose-response models.

Maloney A, Simonsson US, Schaddelee M.

J Pharmacokinet Pharmacodyn. 2013 Apr;40(2):201-11. doi: 10.1007/s10928-013-9300-x. Epub 2013 Feb 19.


Moxifloxacin population pharmacokinetics in patients with pulmonary tuberculosis and the effect of intermittent high-dose rifapentine.

Zvada SP, Denti P, Geldenhuys H, Meredith S, van As D, Hatherill M, Hanekom W, Wiesner L, Simonsson US, Jindani A, Harrison T, McIlleron HM.

Antimicrob Agents Chemother. 2012 Aug;56(8):4471-3. doi: 10.1128/AAC.00404-12. Epub 2012 May 14.


Population pharmacokinetics of lopinavir and ritonavir in combination with rifampicin-based antitubercular treatment in HIV-infected children.

Zhang C, McIlleron H, Ren Y, van der Walt JS, Karlsson MO, Simonsson US, Denti P.

Antivir Ther. 2012;17(1):25-33. doi: 10.3851/IMP1915.


A semimechanistic pharmacokinetic-enzyme turnover model for rifampin autoinduction in adult tuberculosis patients.

Smythe W, Khandelwal A, Merle C, Rustomjee R, Gninafon M, Bocar Lo M, Sow OB, Olliaro PL, Lienhardt C, Horton J, Smith P, McIlleron H, Simonsson US.

Antimicrob Agents Chemother. 2012 Apr;56(4):2091-8. doi: 10.1128/AAC.05792-11. Epub 2012 Jan 17.


Model-based approach to dose optimization of lopinavir/ritonavir when co-administered with rifampicin.

Zhang C, Denti P, Decloedt E, Maartens G, Karlsson MO, Simonsson US, McIlleron H.

Br J Clin Pharmacol. 2012 May;73(5):758-67. doi: 10.1111/j.1365-2125.2011.04154.x.


Non-linear mixed effects modeling of antiretroviral drug response after administration of lopinavir, atazanavir and efavirenz containing regimens to treatment-naïve HIV-1 infected patients.

Röshammar D, Simonsson US, Ekvall H, Flamholc L, Ormaasen V, Vesterbacka J, Wallmark E, Ashton M, Gisslén M.

J Pharmacokinet Pharmacodyn. 2011 Dec;38(6):727-42. doi: 10.1007/s10928-011-9217-1. Epub 2011 Oct 2.


Population pharmacokinetics of ethambutol in South African tuberculosis patients.

Jönsson S, Davidse A, Wilkins J, Van der Walt JS, Simonsson US, Karlsson MO, Smith P, McIlleron H.

Antimicrob Agents Chemother. 2011 Sep;55(9):4230-7. doi: 10.1128/AAC.00274-11. Epub 2011 Jun 20.


Variability in the population pharmacokinetics of isoniazid in South African tuberculosis patients.

Wilkins JJ, Langdon G, McIlleron H, Pillai G, Smith PJ, Simonsson US.

Br J Clin Pharmacol. 2011 Jul;72(1):51-62. doi: 10.1111/j.1365-2125.2011.03940.x.


Modelling of pain intensity and informative dropout in a dental pain model after naproxcinod, naproxen and placebo administration.

Björnsson MA, Simonsson US.

Br J Clin Pharmacol. 2011 Jun;71(6):899-906. doi: 10.1111/j.1365-2125.2011.03924.x.


An example of optimal phase II design for exposure response modelling.

Maloney A, Schaddelee M, Freijer J, Krauwinkel W, van Gelderen M, Jacqmin P, Simonsson US.

J Pharmacokinet Pharmacodyn. 2010 Oct;37(5):475-91. doi: 10.1007/s10928-010-9168-y. Epub 2010 Sep 25.


Population pharmacokinetics of lopinavir in combination with rifampicin-based antitubercular treatment in HIV-infected South African children.

Elsherbiny D, Ren Y, McIlleron H, Maartens G, Simonsson US.

Eur J Clin Pharmacol. 2010 Oct;66(10):1017-23. doi: 10.1007/s00228-010-0847-9. Epub 2010 Jun 16.


Effects of four different meal types on the population pharmacokinetics of single-dose rifapentine in healthy male volunteers.

Zvada SP, Van Der Walt JS, Smith PJ, Fourie PB, Roscigno G, Mitchison D, Simonsson US, McIlleron HM.

Antimicrob Agents Chemother. 2010 Aug;54(8):3390-4. doi: 10.1128/AAC.00345-10. Epub 2010 Jun 1.


A two-compartment effect site model describes the bispectral index after different rates of propofol infusion.

Björnsson MA, Norberg A, Kalman S, Karlsson MO, Simonsson US.

J Pharmacokinet Pharmacodyn. 2010 Jun;37(3):243-55. doi: 10.1007/s10928-010-9157-1. Epub 2010 Apr 23.


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