Publications
Publications are a key element to disseminate PharMetrX's research results—in addition to, e.g., talks and poster presentations at workshops and conferences. We communicate our results to the pharmacometrics community and beyond, to practitioners and clinicians.
Please find below the list of peer-reviewed original & review articles, book chapters by PharMetrX PhD students of the two PharMetrX Chairs at Freie Universität Berlin and the University of Potsdam. For PhD theses, please click here.
Peer reviewed articles & Review contributions & Book chapters
2024
- A.M. Mc Laughlin#, T. Helland#, F. Klima, S. Koolen, R. van Schaik, R. Mathijssen, P. Neven, J. Swen, H.-J. Guchelaar, F. Dalenc, M. White-Koning, R. Michelet, G. Mikus, W. Schroth, T. Mürdter, H. Brauch, M. Schwab, G. Mellgren, F. Thomas, C. Kloft*, D. Hertz* on behalf of the CYP2D6 Endoxifen Percentage Activity Model (CEPAM) consortium.
Nonlinear mixed-effects model of Z-endoxifen concentrations in tamoxifen-treated patients from the CEPAM cohort.
#shared first authorship
*shared senior authorship
Clin. Pharmacol. Ther. 116: 690-702 (2024). - D. Bindellini, R. Michelet, L.B.S. Aulin, J. Melin, U. Neuman, O. Blankenstein, W. Huisinga, M.J. Whitaker, R. Ross, C. Kloft.
A quantitative modeling framework to understand the physiology of the hypothalamic-pituitary-adrenal axis and interaction with cortisol replacement therapy.
J. Pharmacokinet. Pharmacodyn. 51: 809-824 (2024). - M. Mc Laughlin#, D. Hess#, R. Michelet, I. Colombo, S. Haefliger, S. Bastian, M. Rabaglio, M. Schwitter, S. Fischer, K. Eckhardt, S. Hayoz, C. Kopp, M. Klose, C. Sessa, A. Stathis, S. Halbherr, W. Huisinga, M. Joerger*, C. Kloft*.
Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin in a phase I trial.
#shared first authorship
*shared senior authorship - A. Saleh, J. Schulz, J.F. Schlender, L. B.S. Aulin, A.P. Konrad, F. Kluwe, G. Mikus, W. Huisinga, C. Kloft#, R. Michelet#.
Understanding voriconazole metabolism: a middle-out physiologically-based pharmacokinetic modelling framework integrating in vitro and clinical insights.
#shared senior authorship
Clin. Pharmacokinet. 63:1609-1630 (2024). - I.K. Minichmayr, S.G. Wicha, P. Matzneller, C. Kloft, M. Zeitlinger.
Impact of key components of intensified ceftaroline dosing on pharmacokinetic/pharmacodynamic target attainment.
Clin. Pharmacokinet. 63: 121–131 (2024). - C. Steenholdt, R.D. Lorentsen, P.N. Petersen, E.S.K. Widigson, C. Kloft, R.A. Klaasen, Jørn Brynskov.
Therapeutic drug monitoring of vedolizumab therapy in inflammatory bowel disease.
J. Gastroenterol. Hepatol. 39: 1088-1098 (2024). - U. Falkenhagen, L. H. Cavallari, J. D. Duarte, C. Kloft, S. Schmidt, W. Huisinga.
Leveraging QSP Models for MIPD: A Case Study for Warfarin/INR.
Clin. Pharmacol. Ther. 116: 795-806 (2024). - J. Knöchel, C. Kloft, W. Huisinga.
Index analysis: an approach to understand signal transduction with application to the EGFR signalling pathway.
PLoS Comput Biol 20: e1011777 (2024). - D. Seeler, N. Grdseloff, C. J. Rödel, C. Kloft, S. Abdelilah-Seyfried, W. Huisinga.
Novel mathematical approach to accurately quantify 3D endothelial cell morphology and vessel geometry based on fluorescently marked endothelial cell contours: Application to the dorsal aorta of wild-type and Endoglin-deficient zebrafish embryos.
PLoS Comput. Biol. 20: e1011924 (2024). - O. Hölsken, K. Sponheuer, F. Weber, J. Martens-Lobenhoffer, S.M. Bode-Böger, C. Kloft, S. Treskatsch, S. Angermair.
First clinical application of aztreonam–avibactam in treating carbapenem-resistant enterobacterales: insights from Therapeutic Drug Monitoring and pharmacokinetic simulations.
J. Pers. Med. 14: 1135 (2024). - I. Colombo, K.-L. Koster, L. Holer, S. Hgebuaefliger, M. Rabaglio, S. Bastian, M. Schwitter, K. Eckhardt, S. Hayoz, A.M. Mc Laughlin, C. Kloft, M. Klose, S. Halbherr, C. Baumgartner, C. Sessa, A. Stathis, D. Hess, M. Joerger.
TLD-1, a novel liposomal doxorubicin, in patients with advanced solid tumors: dose escalation and expansion part of a multicenter open-label phase I trial (SAKK 65/16).
Eur. J. Cancer. 201: 113588 (2024). - A. Lehmann, I. Geburek, S. Hessel-Pras, A.M. Enge, H. Mielke, C. Müller-Graf, C. Kloft, C. Hethey.
PBTK model-based analysis of CYP3A4 induction and the toxicokinetics of the pyrrolizidine alkaloid retrorsine in man.
Arch. Toxicol. 98: 1757-1769 (2024). - Z. Duvnjak, F.S. Stark, V. Cosson, S. Retout, E. Schindler, J.A. Abrantes.
Simulation-based evaluation of the Pharmpy Automatic Model Development tool for population pharmacokinetic modeling in early clinical drug development.
CPT Pharmacometrics Syst. Pharmacol. 13: 1707-1721 (2024). - A. Ernst, U. Falkenhagen, S. Winkelmann.
Model reduction for Ca2+-induced vesicle fusion dynamics.
Proceedings in Applied Mathematics and Mechanics (2024).
2023
- F. Kluwe, R. Michelet, W. Huisinga, M. Zeitlinger, G. Mikus, C. Kloft.
Towards model-informed precision dosing of voriconazole: Challenging published voriconazole nonlinear mixed-effects models with real-world clinical data.
Clin. Pharmacokinet. 62: 1461-1477 (2023). - R. Michelet, D. Bindellini, J. Melin, U. Neumann, O. Blankenstein, W. Huisinga, T. Johnson, M. J. Whitaker, R. Ross, C. Kloft.
Insights in the maturational processes influencing hydrocortisone pharmacokinetics in congenital adrenal hyperplasia patients using a middle-out approach.
Front. Pharmacol.13: 1090554 (2023). - V. Stachanow, U. Neumann, O. Blankenstein, N. Alder-Baerens, D. Bindellini, P. Hindmarsh, R. Ross, M.J. Whitaker, J. Melin, W. Huisinga, R. Michelet, C. Kloft.
Model-informed target morning 17α-hydroxyprogesterone concentrations in dried blood spots for pediatric congenital adrenal hyperplasia patients.
Pharmaceuticals 16: 464 (2023). - F. W. Ojara, A. Henrich, N. Frances, Y. M. Nassar, W. Huisinga, N. Hartung, K. Geiger, S. Holdenrieder, M. Joerger, C. Kloft.
A prognostic baseline blood biomarker and tumor growth kinetics integrated model in paclitaxel/platinum treated advanced non-small cell lung cancer patients.
CPT: Pharmacometrics & Systems Pharmacology (2023). - Y.M. Nassar, F.W. Ojara, A. Pérez-Pitarch, K. Geiger, W. Huisinga, N. Hartung, R. Michelet, S. Holdenrieder, M. Joerger*, C. Kloft*.
C-reactive protein as an early predictor of efficacy in advanced non-small cell lung cancer patients: A tumor dynamics-biomarker modeling framework.
Cancers 15:5429 (2023).
*shared senior authorship - S. Stübler, C. Kloft, W. Huisinga.
Cell-level systems biology model to study inflammatory bowel diseases and their treatment options.
CPT: Pharmacometrics Syst. Pharmacol. 12: 690-705 (2023). - U. Falkenhagen, C. Himpe, J. Knöchel, C. Kloft, W. Huisinga.
Sample-based robust model reduction for non-linear systems biology models.
Proc. Appl. Math. Mech. e202200269 (2023). - U. Falkenhagen, J. Knöchel, C. Kloft, W. Huisinga.
Deriving mechanism-based pharmacodynamic models by reducing quantitative systems pharmacology models: An application to warfarin.
CPT: Pharmacometrics Syst. Pharmacol. 12: 432-443 (2023). - A. Lehmann, I. Geburek, A. These, S. Hessel-Pras, J.G. Hengstler, W. Albrecht, H. Mielke, C. Müller-Graf, X. Yang, C. Kloft, C. Hethey.
PBTK modeling of the pyrrolizidine alkaloid retrorsine to predict liver toxicity in mouse and rat.
Arch. Toxicol. 7: 1319-1333 (2023). - O. Teplytska#, F. Klima#, N. Haas, C. Kloft*, U. Jaehde*.
One dose to treat them all? – Therapeutisches Drug Monitoring zur Dosisoptimierung in der oralen Tumortherapie.
Best Practice Onkologie 18: 258-261 (2023).
#equal contribution
*shared senior authorship - R. Michelet, L.B.S. Aulin, J.M. Borghardt, T. Dalla Costa, P. Denti, M. Ibarra, G. Ma, B. Meibohm, G. Pillai, S. Schmidt, S. Hennig, C. Kloft.
Barriers to global pharmacometrics: educational challenges and opportunities across the globe.
CPT Pharmacometrics Syst Pharmacol. 12: 743-747 (2023).
2022
- F.A. Weinelt, M.S. Stegemann, A. Theloe, F. Pfäfflin, S. Achterberg, F. Weber, L. Dübel, A. Mikolajewska, A. Uhrig, P. Kiessling, W. Huisinga, R. Michelet, S. Hennig, C. Kloft.
Evaluation of a meropenem and piperacillin monitoring program in intensive care unit patients calls for the regular assessment of empirical targets and easy-to-use dosing decision tools.
Antibiotics 11: 758 (2022). - J. Schulz, A. Thomas, A. Saleh, G. Mikus, C. Kloft*, R. Michelet*.
Towards the elucidation of the pharmacokinetics of voriconazole: a quantitative characterization of its metabolism.
Pharmaceutics. 14: 477 (2022).
*shared senior authorship - D. Busse*, P. Simon*, L. Schmitt, D. Petroff, C. Dorn, A. Dietrich, M. Zeitlinger, W. Huisinga, R. Michelet, H. Wrigge, C. Kloft.
Comparative plasma and interstitial tissue fluid pharmacokinetics of meropenem demonstrate the need for increasing dose and infusion duration in obese and non-obese patients.
Clin. Pharmacokinet. 61: 655-672 (2022).
*equal contribution - D. Busse*, P. Simon*, D. Petroff, N. El-Najjar, L. Schmitt, D. Bindellini, A. Dietrich, M. Zeitlinger, W. Huisinga, R. Michelet, H. Wrigge, C. Kloft.
High-dosage fosfomycin results in adequate plasma and target-site exposure in morbidly obese and nonobese nonhyperfiltration patients.
Antimicrob. Agents Chemother. 66: e0230221 (2022).
*equal contribution - D. Busse, J.M. Borghardt, D. Petroff, A. Pevzner, C. Dorn, N. El-Najjar, W. Huisinga, H. Wrigge, P. Simon, C. Kloft.
Evaluating prediction methods for glomerular filtration to optimise drug doses in obese and nonobese patients.
Br. J. Clin. Pharmacol. 88: 2973-2981 (2022). - V. Stachanow, U. Neumann, O. Blankenstein, D. Bindellini, J. Melin, R. Ross, M.J. Whitaker, W. Huisinga, R. Michelet*ǂ, C. Kloftǂ.
Exploring dried blood spot cortisol concentrations as an alternative for monitoring pediatric adrenal insufficiency patients: A model-based analysis.
Frontiers Pharmacol. 13: 1-8 (2022).
ǂshared senior authorship
*corresponding author - Y.M. Nassar#, N. Hohmann#, R. Michelet, K. Gottwalt, A.D. Meid, J. Burhenne, W. Huisinga, W.E Haefeli, G. Mikus*, C. Kloft*.
Quantification of the time course of CYP3A inhibition, activation, and induction using a population pharmacokinetic model of microdosed midazolam continuous infusion.
Clin. Pharmacokinet. 61: 1595-1607 (2022).
#shared first authorship
*shared senior authorship - C. Maier, J. de Wiljes, N. Hartung, C. Kloft, W. Huisinga.
A continued learning approach for model-informed precision dosing: updating models in clinical practice.
CPT: Pharmacometrics Syst. Pharmacol. 11: 185-198 (2022). - C. Scharf, F. Weinelt, I. Schroeder, M. Paal, M. Weigand, M. Zoller, M. Irlbeck, C. Kloft, J. Briegel, U. Liebchen.
Does the cytokine adsorber CytoSorb® reduce vancomycin exposure in critically ill patients with sepsis or septic shock? A prospective observational study.
Ann. Intensive Care 12: 44 (2022). - U. Liebchen#, F. Weinelt#, C. Scharf, I. Schroeder, M. Paal, M. Zoller, C. Kloft, J. Jung*, R. Michelet*
Combination of pharmacokinetic and pathogen susceptibility information to optimize meropenem treatment of gram-negative infections in critically ill patients.
Antimicrob. Agents Chemother. 66: 2 (2022).
#shared first authorship
*shared senior authorship - M. van Dyk, C. Boylan, R. Michelet, A.M. Mc Laughlin, G. Kichenadasse, N. May,
V. Ziesenitz, J. van den Anker, S.L. Groenland, A. Huitema, N. Steeghs, G. Mikus, C. Kloft, H. Tapp.
Plasma concentration guided dosing of drugs used for the treatment of childhood leukaemias: Protocol for a systematic review.
BMJ Open 12: e053308 (2022). - A. Démaris, E.S.K. Widigson, J.F.K.F. Ilvemark, C. Steenholdt, J.B. Seidelin, W. Huisinga, R. Michelet, L.B.S. Aulin, C. Kloft.
Ulcerative colitis and acute severe ulcerative colitis patients are overlooked in infliximab population pharmacokinetic models: Results from a comprehensive review.
Pharmaceutics 14: 2095 (2022).
2021
- F. Kluwe, R. Michelet, A. Mueller-Schoell, C. Maier, L. Klopp-Schulze, M. van Dyk, G. Mikus, W. Huisinga, C. Kloft.
Perspectives on model-informed precision dosing in the digital health era: Challenges, opportunities, and recommendations.
Clin. Pharmacol. Ther. 109: 29-36 (2021). - A. Mueller-Schoell, N. Puebla-Osorio, R. Michelet, M. Green, A. Künkele, W. Huisinga, P. Strati, B. Chasen, S.S. Neelapu*, C. Yee*, C. Kloft*.
Early survival prediction framework in CD19-specific CAR-T-cell immunotherapy using a population quantitative systems pharmacology model.
Cancers 13: 2782 (2021).
*shared senior authorship - A. Mueller-Schoell, R. Michelet, L. Klopp-Schulze, M. van Dyk, T.E. Mürdter, M. Schwab, M. Joerger, W. Huisinga, G. Mikus, C. Kloft.
Computational treatment simulations to assess the need for personalized tamoxifen dosing in breast cancer patients of different biogeographical groups.
Cancers 13: 2432 (2021). - A. Mueller-Schoell, L. Klopp-Schulze, R. Michelet, M. Van Dyk, T.E. Mürdter, M. Schwab, M. Joerger, W. Huisinga, G. Mikus, C. Kloft.
Simulation-based assessment of the impact of non-adherence on endoxifen target attainment in different tamoxifen dosing strategies.
Pharmaceuticals 14: 115 (2021). - A.M. Mc Laughlin, E. Schmulenson, O. Teplytska, S. Zimmermann, P. Opitz, S.L. Groenland, A. Huitema, N. Steeghs, L. Mueller, S. Fuxius, G. Illerhaus, M. Joerger, F. Mayer, U. Fuhr, S. Holdenrieder, G. Hempel, O. Scherf-Clavel, G. Mikus, U. Jaehde, C. Kloft for the ON-TARGET Study consortium.
Developing a nationwide infrastructure for Therapeutic Drug Monitoring of targeted oral anticancer drugs: The ON-TARGET study protocol.
Cancers 13: 6281 (2021). - D. Busse, P. Simon, D. Petroff, C. Dorn, L. Schmitt, D. Bindellini, A. Kratzer, A. Dietrich, M. Zeitlinger, W. Huisinga, R. Michelet, H. Wrigge, C. Kloft.
Similar piperacillin/tazobactam target attainment in obese versus nonobese patients despite differences in interstitial tissue fluid pharmacokinetics.
Pharmaceutics 13: 1380 (2021). - D. Busse#, P. Simon#, R. Michelet, L. Ehmann, F. Mehner, C. Dorn, A. Kratzer, W. Huisinga, H. Wrigge, D. Petroff*, C. Kloft*.
Quantification of microdialysis related variability in humans: Clinical trial design recommendations.
Eur. J. Pharm. Sci. 157: 105607 (2021).
#equal contribution, *shared senior authorship - D. Busse#, A. Schaeftlein#, A. Solms, L. Ilia, R. Michelet, M. Zeitlinger, W. Huisinga, C. Kloft.
Which analysis approach is adequate to leverage clinical microdialysis data? A quantitative comparison to investigate exposure and response exemplified by levofloxacin.
Pharm. Res. 38: 381–395 (2021).
#equal contribution - S. Franck, R. Michelet, F. Casilag, J.C. Sirard, S.G. Wicha*, C. Kloft*.
A model-based pharmacokinetic/pharmacodynamic analysis of the combination of amoxicillin and monophosphoryl lipid A against S. pneumoniae in mice.
Pharmaceutics 13: 469 (2021).
*equal contribution - R. Michelet, M. Ursino, S. Boulet, S. Franck, F. Casilag, M. Baldry, J. Rolff, M. van Dyk, S. G. Wicha, J.C. Sirard, E. Comets, S. Zohar*, C. Kloft*.
The use of translational modelling and simulation to develop immunomodulatory therapy as an adjunct to antibiotic treatment in the context of pneumonia.
Pharmaceutics 13: 601 (2021).
*shared senior authorship - F. Weinelt, M. Stegemann, A. Theloe, F. Pfäfflin, S. Achterberg, L. Schmitt, W. Husinga, R. Michelet, S. Hennig, C. Kloft.
Development of a model-informed dosing tool to optimise initial antibiotic dosing - a translational example for intensive care units.
Pharmaceutics 13:2128 (2021). - U. Liebchen, M. Klose, M. Paal, M. Vogeser, M. Zoller, I. Schroeder, L. Schmitt, W. Huisinga, R. Michelet, J. Zander, C. Scharf, F. Weinelt*, C. Kloft*.
Evaluation of the MeroRisk Calculator, a user-friendly tool to predict the risk of meropenem target non-attainment in critically ill patients.
Antibiotics 10: 468 (2021).
*shared senior authorship - U. Liebchen, C. Scharf, M. Zoller, F. Weinelt*, C. Kloft*.
No clinically relevant removal of meropenem by cytokine adsorber CytoSorb® in critically ill patients with sepsis or septic shock.
Intensive Care Med. 47: 1332–1333 (2021).
*shared senior authorship - V. Stachanow, U. Neumann, O. Blankenstein, U. Fuhr, W. Huisinga, R. Michelet, N. Reisch*, C. Kloft*
Rationale of a lower dexamethasone dose in prenatal congenital adrenal hyperplasia therapy based on pharmacokinetic modelling.
Eur. J. Endocrinol. 185: 365-374 (2021).
*shared senior authorship - M. Paal, C. Scharf, A. Denninger, L. Ilia, C. Kloft, N. Kneidinger, U. Liebchen, S. Michel, C. Schneider, S. Schröpf, C. Schuster, M. Vogeser, F. Weinelt, J. Zander, M. Zoller, I. Schroeder.
Target site pharmacokinetics of meropenem: Measurement in human explanted lung tissue by bronchoalveolar lavage, microdialysis, and homogenized lung tissue.
Antimicrob. Agents Chemother. 65: 12 (2021). - A.M. Grisic#, M. Dorn-Rasmussen#, B. Ungar, J. Brynskov, J.F. Ilvemark, N. Bolstad, D.J. Warren, M.A. Ainsworth, W. Huisinga, S. Ben-Horin, C. Kloft*, C. Steenholdt*.
Infliximab clearance decreases in second and third trimesters of pregnancy in inflammatory bowel disease.
United Eur. Gastroenterol. J. 9: 91-101 (2021).
#equal contribution, *shared senior authorship - A.‐M. Grisic, A. Eser, W. Huisinga, W. Reinisch, C. Kloft
Quantitative relationship between infliximab exposure and inhibition of C‐reactive protein synthesis to support inflammatory bowel disease management.
Br. J. Clin. Pharmacol. 87: 2374-2384 (2021). - A. Mueller-Schoell, R. Michelet, F. Weinelt, C. Kloft, G. Mikus.
CYP2D6 phenotype explains reported yohimbine concentrations in four severe acute intoxications.
Arch. Toxicol. 95: 2867-2870 (2021). - C. Maier, N. Hartung, C. Kloft, W. Huisinga, J. de Wiljes.
Reinforcement learning and Bayesian data assimilation for model-informed precision dosing in oncology.
CPT: Pharmacometrics Syst. Pharmacol. 10: 241-254 (2021). - M. van Dyk, N. Bulamu, C. Boylan, A.M. Mc Laughlin, G. Kichenadasse, N. May, R. Michelet, C. Kloft, B. Kaambwa.
Cost-effectiveness of oral anti-cancer drugs and associated individualised dosing approaches in cancer patients: Protocol for a systematic review and meta-analysis.
BMJ Open 11: e047173 (2021). - F. Casilag, L. Matarazzo, S. Franck, M. Figeac, R. Michelet, C. Kloft, C. Carnoy, J.C. Sirard.
The biosynthetic monophosphoryl lipid A enhances the therapeutic outcome of antibiotic therapy in pneumococcal pneumonia.
ACS Infectious Diseases. 7: 2164-2175 (2021). - A. Mueller-Schoell, S.L. Groenland, O. Scherf-Clavel, M. van Dyk, W. Huisinga, R. Michelet, U. Jaehde, N. Steeghs, A.D.R. Huitema, C. Kloft.
Therapeutic drug monitoring of oral targeted antineoplastic drugs.
Eur. J. Clin. Pharmacol. 77: 441-464 (2021). - A. Mueller-Schoell, S.L. Groenland, O. Scherf-Clavel, M. van Dyk, W. Huisinga, R. Michelet, U. Jaehde, N. Steeghs, A.D.R. Huitema, C. Kloft.
Correction to: Therapeutic drug monitoring of oral targeted antineoplastic drugs.
Eur. J. Clin. Pharmacol. 77: 465 (2021). - M. Muth, F.W. Ojara, C. Kloft, M. Joerger.
Role of TDM-based dose adjustments for taxane anticancer drugs.
Br. J. Clin. Pharmacol. 87: 306–316 (2021)
2020
- L. Ehmann#, P. Simon#, D. Busse#, D. Petroff, C. Dorn, W. Huisinga, A. Dietrich, M. Zeitlinger, H. Wrigge*, C. Kloft*.
Risk of target non-attainment in obese compared to non-obese patients in calculated linezolid therapy.
Clin. Microbiol. Infect. 26: 1222-1228 (2020).
#equal contribution, *shared senior authorship - R. Michelet, J. Melin, Z.P. Parra-Guillen, U. Neumann, M.J. Whitaker, V. Stachanow, W. Huisinga, J. Porter, O. Blankenstein, R.J. Ross, C. Kloft.
Paediatric population pharmacokinetic modelling to assess hydrocortisone replacement dosing regimens in young children.
Eur. J. Endocrinol. 183: 357-368 (2020). - R. Michelet, J. Melin, Z.P. Parra-Guillen, U. Neumann, M.J. Whitaker, V. Stachanow, W. Huisinga, J. Porter, O. Blankenstein, R.J. Ross, C. Kloft.
Response to ‘Hydrocortisone suspension formulations are not necessarily the same in the treatment of children with congenital adrenal hyperplasia’.
Eur. J. Endocrinol. 183: L29-L30 (2020). - J. Melin, Z.P. Parra-Guillen, R. Michelet, T. Truong, W. Huisinga, N. Hartung, P. Hindmarsh, C. Kloft.
Pharmacokinetic/pharmacodynamic evaluation of hydrocortisone therapy in pediatric patients with congenital adrenal hyperplasia
J. Clin. Endocrinol. Metab. 105: 1-12 (2020). - A. Mueller-Schoell, L. Klopp-Schulze, W. Schroth, T. Mürdter, R. Michelet, H. Brauch, W. Huisinga, M. Joerger, P. Neven, S.L.W. Koolen, R.H.J. Mathijssen, E. Copson, D. Eccles, S. Chen, B. Chwobay, A. Tfayli, N.K. Zgheib, M. Schwab, C. Kloft.
Obesity alters endoxifen plasma levels in young breast cancer patients: A pharmacometric simulation approach.
Clin. Pharmacol. Ther. 108: 661-670 (2020). - L. Klopp-Schulze#, A. Mueller-Schoell#, P. Neven, S.L. Koolen, R.H.J. Mathijssen, M. Joerger, C. Kloft.
Integrated data analysis of six clinical studies points toward model-informed precision dosing of tamoxifen.
Front. Pharmacol. 11: 283 (2020).
#equal contribution - F.W. Ojara, A. Henrich, N. Frances, W. Huisinga, N. Hartung, M. Joerger, C. Kloft.
Time-to-event analysis of paclitaxel-associated peripheral neuropathy in advanced non-small cell lung cancer highlighting key influential treatment/patient factors.
J. Pharmacol. Exp. Ther. 375: 430-438 (2020). - A.M. Grisic, A. Khandelwal, M. Bertolino, W. Huisinga, P. Girard, C. Kloft.
Semimechanistic clearance models of oncology biotherapeutics and impact of study design: Cetuximab as a case study.
CPT: Pharmacometrics Syst. Pharmacol. 9: 628-638 (2020). - P. Simon#, D. Busse#, D. Petroff, C. Dorn, L. Ehmann, S. Hochstäd, F. Girrbach, A. Dietrich, M. Zeitlinger, F. Kees, C. Kloft*, H. Wrigge*.
Linezolid concentrations in plasma and subcutaneous tissue are reduced in obese patients, resulting in a higher risk of underdosing in critically ill patients: A controlled clinical pharmacokinetic study.
J. Clin. Med. 9: 1067 (2020).
#equal contribution, *shared senior authorship - C. Maier, N. Hartung, J. de Wiljes, C. Kloft, W. Huisinga.
Bayesian data assimilation to support informed decision‐making in individualized chemotherapy.
CPT: Pharmacometrics Syst. Pharmacol. 9: 153-164 (2020). - J. Grensemann, D. Busse, C. König, W. Jäger, D. Jarczak, S. Iwersen-Bergmann, C. Kloft, S. Kluge, V. Fuhrmann.
Pharmacokinetics of meropenem in critically ill patients with and without acute-on-chronic liver failure undergoing continuous venovenous hemodialysis.
Ann. Intensive Care 10: 1-10 (2020). - P. Simon, D. Petroff, D. Busse, J. Heyne, F. Girrbach, A. Dietrich, A. Kratzer, M. Zeitlinger, C. Kloft, F. Kees, H. Wrigge, C. Dorn.
Meropenem plasma and interstitial soft tissue concentrations in obese and non-obese patients – a controlled clinical trial.
Antibiotics 9: 931 (2020).
2019
- L. Ehmann, M. Zoller, I.K. Minichmayr, C. Scharf, W. Huisinga, J. Zander, C. Kloft.
Development of a dosing algorithm for meropenem in critically ill patients based on a population pharmacokinetic/pharmacodynamic analysis.
Int. J. Antimicrob. Agents 54: 309-317 (2019). - J. Melin, N. Hartung, Z.P. Parra-Guillen, M.J. Whitaker, R.J. Ross, C. Kloft.
The circadian rhythm of corticosteroid-binding globulin has little impact on cortisol exposure after hydrocortisone dosing.
Clin. Endocrinol. 91: 33-40 (2019). - H. Edlund#, A.M. Grisic#, C. Steenholdt, M.A. Ainsworth, J. Brynskov, W. Huisinga, C. Kloft.
Absence of relationship between CDAI or CRP and infliximab exposure calls for use of objective Crohn’s disease activity measures for evaluation of treatment effects at treatment failure.
Ther. Drug Monit. 41: 235-242 (2019).
#equal contribution - C. Kirbs#, F. Kluwe#, F. Drescher, J. Weiss, P. Matzneller, M. Zeitlinger*, C. Kloft*.
High voriconazole target-site exposure after approved sequence dosing due to nonlinear pharmacokinetics assessed by long-term microdialysis.
Eur. J. Pharm. Sci. 131: 218-229 (2019).
#equal contribution, *shared senior authorship - S. Franck, T. Fuhrmann-Selter, J.F. Joseph, R. Michelet, F. Casilag, J.C. Sirard, S.G. Wicha, C. Kloft.
A rapid, simple and sensitive liquid chromatography tandem mass spectrometry assay to determine amoxicillin concentrations in biological matrix of little volume.
Talanta 201: 253-258 (2019). - P. Simon, D. Petroff, C. Dorn, L. Ehmann, C. Kloft, C. Prettin, A. Dietrich, M. Zeitlinger, F. Kees, H. Wrigge.
Measurement of soft tissue drug concentrations in morbidly obese and non-obese patients – a controlled clinical trial.
Contemp Clin Trials Commun. 15: 100375 (2019). - J. Schulz, F. Kluwe, G. Mikus, R. Michelet, C. Kloft.
Novel insights into the complex pharmacokinetics of voriconazole: a review of its metabolism.
Drug Metab. Rev. 51: 247-265 (2019).
2018
- J. Melin, Z.P. Parra-Guillen, N. Hartung, W. Huisinga, R.J. Ross, M.J. Whitaker, C. Kloft.
Predicting cortisol exposure from paediatric hydrocortisone formulation using a semi-mechanistic pharmacokinetic model established in healthy adults.
Clin. Pharmacokinet. 57: 515-527 (2018). - I.K. Minichmayr, J.A. Roberts, O.R. Frey, A.C. Roehr, C. Kloft, A. Brinkmann.
Development of a dosing nomogram for continuous infusion meropenem in critically ill patients based on a validated population pharmacokinetic model.
J. Antimicrob. Chemother. 73: 1330-1339 (2018). - J. Knöchel, C. Kloft, W. Huisinga.
Understanding and reducing complex systems pharmacology models based on a novel input-response index
J Pharmacokinet Pharmacodyn 45: 139-157 (2018). - M.G. Vossen, L. Ehmann, S. Pferschy, A. Maier-Salamon, M. Haidinger, C. Weiser, J.M. Wenisch, K. Saria, C. Kajahn, S. Jilch, R. Lemmerer, M. Bécède, M. Zeitlinger, C. Kloft, W. Jäger, F. Thalhammer.
Elimination of doripenem during dialysis and pharmacokinetic evaluation of posthemodialysis dosing for patients undergoing intermittent renal replacement therapy.
Antimicrob. Agents Chemother. 62: e02430-17 (2018). - L. Klopp-Schulze, M. Joerger, S.G. Wicha, R. ter Heine, C. Csajka, Z.P. Parra-Guillen, C. Kloft.
Exploiting pharmacokinetic models of tamoxifen and endoxifen to identify factors causing subtherapeutic concentrations in breast cancer patients.
Clin. Pharmacokinet. 57: 229-242 (2018). - M. Schulz#, L. Klopp-Schulze#, S. Keilhack, S. Meyer, L. Botermann, C. Kloft.
Adherence to tamoxifen in breast cancer patients – What role does the pharmacist play in German primary care?
Can. Pharm. J. 152: 28-34 (2018).
#equal contribution - L. Klopp-Schulze, C. Kloft.
CYP2D6-Genotypisierung vor Tamoxifen-Therapiestart.
Best Pract Oncol. 13: 325-329 (2018). -
S.G. Wicha, C. Kloft.
Quantitative systems pharmacology in model-informed drug development and therapeutic use.
Curr Opin Syst Biol. 10: 19-25 (2018). -
J.M. Borghardt, C. Kloft, A. Sharma.
Inhaled therapy in respiratory disease: The complex interplay of pulmonary kinetic processes.
Can. Respir. J. 2018: 2732017 (2018).
2017
-
K. Weisser, S. Stübler, W. Matheis, W. Huisinga.
Towards toxicokinetic modelling of aluminium exposure from adjuvants in medicinal products
Regul Toxicol Pharmacol 88: 310-321 (2017). - I.K. Minichmayr, A. Schaeftlein, J.L. Kuti, M. Zeitlinger, C. Kloft.
Clinical determinants of target non-attainment of linezolid in plasma and interstitial space fluid: A pooled population pharmacokinetic analysis with focus on critically ill patients.
Clin. Pharmacokinet. 56: 617-633 (2017). - L. Ehmann, M. Zoller, I.K. Minichmayr, C. Scharf, B. Maier, M.V. Schmitt, N. Hartung, W. Huisinga, M. Vogeser, L. Frey, J. Zander, C. Kloft.
Role of renal function in risk assessment of target non-attainment after standard dosing of meropenem in critically ill patients: A prospective observational study.
Crit Care 21: 263 (2017).
Discussed in an Editorial by M.H. Abdul-Aziz, J. Lipman, J.A. Roberts.
Identifying “at-risk” patients for sub-optimal beta-lactam exposure in critically ill patients with severe infections.
Crit Care 21: 283 (2017) - A. Henrich, M. Joerger, S. Kraff, U. Jaehde, W. Huisinga, C. Kloft, Z.P. Parra-Guillen.
Semimechanistic bone marrow exhaustion pharmacokinetic/pharmacodynamic model for chemotherapy-induced cumulative neutropenia.
J. Pharmacol. Exp. Ther. 362: 347-358 (2017). - H. Edlund, C. Steenholdt, M.A. Ainsworth, E. Goebgen, J. Brynskov, O.Ø. Thomsen, W. Huisinga, C. Kloft.
Magnitude of increased infliximab clearance imposed by anti-infliximab antibodies in Crohn’s disease is determined by their concentration.
AAPS J. 19: 223-233 (2017). - S. Fuhrman, C. Kloft, W. Huisinga.
Impact of altered endogenous IgG on unspecific mAb cleareance.
J. Pharmacokinet. Pharmacodyn. 44: 351-374 (2017). - Z. Oesterreicher, I.K. Minichmayr, R. Sauermann, D. Marhofer, E. Lackner, W. Jäger, A. Maier-Salamon, R. Schwameis, C. Kloft, M. Zeitlinger.
Pharmacokinetics of doripenem in plasma and epithelial lining fluid (ELF): Comparison of two dosage regimens.
Eur. J. Clin. Pharmacol. 73: 1609-1613 (2017). - J. Melin, S. Prothon, C. Kloft, A. Cleton, C. Johansson, C. Jorup, B. Olsson, U.W. Hamrén.
Pharmacokinetics of the inhaled selective glucocorticoid receptor modulator AZD5423 following inhalation using different devices.
AAPS J. 19: 865-874 (2017). - U. Jaehde, I.K. Minichmayr, C. Kloft.
Pharmakometrie.
In: U. Jaehde, R. Radziwill, C. Kloft (eds.): Klinische Pharmazie – Grundlagen und Anwendungen, 4. Auflage, Wissenschaftliche Verlagsgesellschaft, Stuttgart/Germany, 4th edition: 50-70 (2017). -
S.G. Wicha, W. Huisinga, C. Kloft.
Translational pharmacometric evaluation of typical antibiotic broad-spectrum combination therapies against staphylococcus aureus exploiting in vitro information.
CPT: Pharmacometrics Syst. Pharmacol. 6: 512-522 (2017).
2016
- M. Joerger, J. von Pawel, S. Kraff, J.R. Fischer, W. Eberhardt, T.C. Gauler, L. Mueller, N. Reinmuth, M. Reck, M. Kimmich, F. Mayer, H.G. Kopp, D.M. Behringer, Y.D. Ko, R.A. Hilger, M. Roessler, C. Kloft, A. Henrich, B. Moritz, M.C. Miller, S.J. Salamone, U. Jaehde.
Open-label, randomised study of individualized, pharmacokinetically (PK)-guided dosing of paclitaxel combined with carboplatin or cisplatin in patients with advanced non-small cell lung cancer (NSCLC).
Ann. Oncol. 27: 1895-1902 (2016). -
J.M. Borghardt, B. Weber, A. Staab, C. Kunz, S. Formella, C. Kloft.
Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach.
Br. J. Clin. Pharmacol. 81: 538–552 (2016). -
J.M. Borghardt, B. Weber, A. Staab, C. Kunz, C. Kloft.
Model-based evaluation of pulmonary pharmacokinetics in asthmatic and COPD patients after oral olodaterol inhalation.
Br. J. Clin. Pharmacol. 82: 739-753 (2016). -
K. Locher, J.M. Borghardt, K.J. Frank, C. Kloft, K.G. Wagner.
Evolution of a mini-scale biphasic dissolution model: Impact of model parameters on partitioning of dissolved API and modelling of in vivo-relevant kinetics.
Eur. J. Pharm. Biopharm. 105: 166-175 (2016). -
S.G. Wicha, C. Kloft.
Simultaneous determination and stability studies of linezolid, meropenem and vancomycin in bacterial growth medium by high-performance liquid chromatography.
J. Chrom. B 1028: 242-248 (2016). -
M.G. Kees, I.K. Minichmayr, S. Moritz, S. Beck, S.G. Wicha, F. Kees, C. Kloft, T. Steinke.
Population pharmacokinetics of meropenem during continuous infusion in surgical ICU patients.
J. Clin. Pharmacol. 56: 307-315 (2016).
2015
- W. Huisinga, S. Fuhrmann, L. Fronton, B.F. Krippendorff
Target driven pharmacokinetics of biopharmaceutics
in Therapeutic Proteins – ADME and translational PK/PD in discovery and development,
H. Zhou and F.-P. Theil (Eds.), Wiley (2015): ISBN 978-1-118-89864-2 - H. Edlund, J. Melin, Z.P. Parra-Guillen, C. Kloft.
Pharmacokinetics and pharmacokinetic–pharmacodynamic relationships of monoclonal antibodies in children.
Clin Pharmacokinet. 54: 35-80 (2015). -
J.M. Borghardt, B. Weber, A. Staab, C. Kloft.
Pharmacometric models for characterizing the plasma and pulmonary pharmacokinetics of orally inhaled drugs.
AAPS J. 17: 853-870 (2015). -
S.G. Wicha, M.G. Kees, J. Kuss, C. Kloft.
Pharmacodynamic and response surface analysis of linezolid or vancomycin combined with meropenem against Staphylococcus aureus.
Pharm. Res. 32: 2410-2418 (2015). -
S.G. Wicha, K. Zink, T. Haak, F. Kees, C. Kloft, M.G. Kees.
Pharmacokinetic/pharmacodynamic analysis of moxifloxacin in patients with diabetic foot infections.
J. Clin. Pharmacol. 55: 639-646 (2015). -
S.G. Wicha, M.G. Kees, A. Solms, I.K. Minichmayr, A. Kratzer, C. Kloft.
TDMx – a novel web-based open-access support tool for optimising antimicrobial dosing regimens in clinical routine.
Int. J. Antimicrob. Agents. 45: 442-444 (2015). -
C. Scheerans, S.G. Wicha, J. Michael, H. Derendorf, C. Kloft.
Concentration–response studies and modelling of the pharmacodynamics of linezolid: Staphylococcus aureus versus Enterococcus faecium.
Int. J. Antimicrob. Agents. 45: 54-60 (2015). - J.M. Borghardt, B. Weber, A. Staab, C. Kloft.
Impact of pulmonary dissolution and pulmonary absorption processes on the pulmonary and systemic pharmacokinetics of inhaled drugs: an in silico analysis.
In: R.N. Dalby, P.R. Byron, J. Peart, J.D. Suman, P.M. Young, D. Traini (eds.): Respiratory Drug Delivery (RDD) Europe 2015. Book 2, Davis Healthcare International Publishing, Nice, France, 299-304 (2015). - B. Weber, I.F. Troconiz, J.M. Borghardt, A. Staab, A. Sharma.
Model-based evaluation of single and multiple dose pharmacokinetics of inhaled tiotropium in healthy volunteers and implications for systemic exposure studies.
In: R.N. Dalby, P.R. Byron, J. Peart, J.D. Suman, P.M. Young, D. Traini (eds.): Respiratory Drug Delivery (RDD) Europe 2015. Book 2, Davis Healthcare International Publishing, Nice, France, 249-254 (2015).
2014
-
J.M. Borghardt, B. Weber, A. Staab, C. Kunz, J. Schiewe, C. Kloft.
Expanding the mechanistic knowledge about pulmonary absorption processes using a population pharmacokinetic model for inhaled olodaterol.
In: R.N. Dalby, P.R. Byron, J. Peart, J.D. Suman, S.J. Farr, P.M. Young, D. Traini (eds.): Respiratory Drug Delivery 2014, Book 2, Davis Healthcare International Publishing, LLC, Illinois, 417-421 (2014). -
U. Liebchen, A. Kratzer, S.G. Wicha, F. Kees, C. Kloft, M.G. Kees.
Unbound fraction of ertapenem in intensive care unit patients.
J. Antimicrob. Chemother. 69: 3108-3111 (2014). -
M.G. Kees, S.G. Wicha, A. Seefeld, F. Kees, C. Kloft.
Unbound fraction of vancomycin in intensive care unit patients.
J. Clin. Pharmacol. 54: 318-323 (2014). - S. Gopalakrishnan, H. Montazeri, S. Menz, N. Beerenwinkel, W. Huisinga
Estimating HIV-1 Fitness Characteristics from Cross-sectional Genotype Data
PLoS Computational Biology, Vol. 10 (2014), e1003886, pp. 1-14 - A. Schaeftlein, I.K. Minichmayr, C. Kloft.
Population pharmacokinetics meets microdialysis: Benefits, pitfalls and necessities of new analysis approaches for human microdialysis data.
Eur. J. Pharm. Sci. 57: 68-73 (2014). - L. Fronton, S. Pilari, W. Huisinga
Monoclonal antibody disposition: a simplified PBPK model and its implications for the derivation and interpretation of classical compartment models
J. Pharmacokinet. Pharmacodyn. 41 (2014), pp 87-107 - O. Kuß, A. Hoyer, A. Solms
Meta-analysis for diagnostic accuracy studies: A new statistical model using beta-binomial distributions and bivariate copulas
Statistics in Medicine 33 (2014), pp. 17-30 - R.B. Eslam, A. Burian, G. Vila, R. Sauermann, A. Hammer, D. Frenzel, I.K. Minichmayr, C. Kloft, P. Matzneller, Z. Oesterreicher, M. Zeitlinger.
Target site pharmacokinetics of linezolid after single and multiple doses in diabetic patients with soft tissue infection.
J. Clin. Pharmacol. 54: 1058-62 (2014). - S. Beck, S.G. Wicha, C. Kloft, M.G. Kees.
Pharmakokinetik and Pharmakodynamik der Antibiotikatherapie.
Der Anaesthesist. 63: 775-782 (2014).
2013
- M.G. Kees, A. Schaeftlein, H.A. Haeberle, F. Kees, C. Kloft, A. Heininger.
Population pharmacokinetics and pharmacodynamic evaluation of intravenous and enteral moxifloxacin in surgical intensive care unit patients.
J. Antimicrob. Chemother. 68: 1331-1337 (2013). - M. Frank, A. Kunz, G. Harms, C. Kloft.
Population pharmacokinetic analysis of a nevirapine-based HIV-1 prevention of mother-to-child transmission program in Uganda to assess the impact of different dosing regimens for newborns.
J. Clin. Pharmacol. 53: 294-304 (2013). - A. Schäftlein, F. Simmel, C. Kloft.
Neue Wege der Dosisoptimierung und individualisierten Pharmakotherapie? Konzentrationsbestimmung von Arzneistoffen und ihre pharmakokinetische Auswertung am Wirkort. Teil 1.
Med. Monatsschr. Pharm. 36: 97-101 (2013). - A. Schäftlein, M. el Talia, C. Kloft.
Neue Wege der Dosisoptimierung und individualisierten Pharmakotherapie? Konzentrationsbestimmung von Arzneistoffen und ihre pharmakokinetische Auswertung am Wirkort. Teil 2.
Med. Monatsschr. Pharm. 36: 147-151 (2013).
2012-2009
- W. Huisinga, A. Solms, L. Fronton, S. Pilari
Modeling inter-individual variability in physiologically-based pharmacokinetics and its link to mechanistic covariate modeling
CPT: Pharmacometrics & Systems Pharmacology, 1 (2012), e4 - M. Frank, M. von Kleist, A. Kunz, G. Harms, C. Schütte, C. Kloft.
Quantifying the Impact of Nevirapine-Based Prophylaxis Strategies To Prevent Mother-to-Child Transmission of HIV-1: a Combined Pharmacokinetic, Pharmacodynamic, and Viral Dynamic Analysis To Predict Clinical Outcomes.
Antimicrob. Agents Chemother., 55: 5529-5540 (2011). - R.A. Keel, A. Schaeftlein, C. Kloft, J. Pope, R. Knauft, D. Nicolau, J.L. Kuti.
Pharmacokinetics of Intravenous and Oral Linezolid in Adults with Cystic Fibrosis.
Antimicrob. Agents Chemother., 55: 3393-3398 (2011). - A. Schaeftlein, C. Kloft.
Die Beers-Liste im klinischen Alltag. Erhöhung der Arzneimitteltherapiesicherheit geriatrischer Patienten.
Arzneimitteltherapiekritik, 3: 219-232 (2011). - S. Unverzagt, M.-T. Machemer, A. Solms, H. Thiele, D. Burkhoff, M. Seyfarth, A. de Waha, E. Magnus Ohman, Michael Buerke, Johannes Haerting, Karl Werdan, Roland Prondzinsky
Intra-aortic balloon pump counterpulsation (IABP) for myocardial infarction complicated by cardiogenic shock
Cochrane Database of Systematic Reviews 6 (2011), CD007398 - A. Schaeftlein, C. Kloft.
Die Beers-Liste im klinischen Alltag. Erhöhung der Arzneimitteltherapiesicherheit geriatrischer Patienten.
Internistische Praxis, 51/3: 617-630 (2011). - S. Pilari, C. Preusse, W. Huisinga.
Gestational Influences on the Pharmacokinetics of Gestagenic Drugs: A Combined In Silico, In Vitro and In Vivo Analysis.
Eur J Pharm Sci. 42: 318-331 (2011). - M. von Kleist, S. Menz, H. Stocker, K. Arasteh, C. Schütte, W. Huisinga.
HIV Quasispecies Dynamics during Pro-Active Treatment Switching: Impact on Multi-Drug Resistance and Resistance Archiving in Latent Reservoirs.
PLoS ONE 6(3): e18204 (2011). - M. von Kleist, S. Menz, W. Huisinga.
Drug-Class Specific Impact of Antivirals on the Reproductive Capacity of HIV.
PLoS Comput Biol 6(3): e1000720 (2010). - S. Pilari, W. Huisinga.
Lumping of Physiologically Based Pharmacokinetic Models and a Mechanistic Derivation of Classical Compartmental Models.
J. Pharmacokinet. Pharmacodyn. 37: 365-405 (2010). - R. Niebecker, C. Kloft.
Safety of therapeutic monoclonal antibodies.
Curr. Drug Saf., 5: 275-286 (2010). - A. Kunz, M. Frank, K. Mugenyi, R. Kabasinguzi, A. Weidenhammer, M. Kurowski, C. Kloft, G. Harms.
Persistance of nevirapine in breast milk and plasma of mothers and their children after single-dose administration.
J. Antimicrob. Chemother., 63: 170-177 (2009).