Publications

Papers

2026

Prior-fitted functional flow: In-context generative models for pharmacokinetics (preprint). Ojeda C, Hartung N, Huisinga W, Jahn T, Kavwele PK, Klose M, Kumar P, Sánchez RJ, Faroughy DA. arXiv · Apr 2026 · doi: 10.48550/arXiv.2604.17670

2025

TLD-1, a novel liposomal doxorubicin, in patients with solid tumors: Comparative pharmacokinetics and final results of a multicenter phase 1 study (SAKK 65/16). Klose M, Colombo I, Gobat K, Koster KL, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Zürrer-Härdi U, Eckhardt K, Hayoz S, Halbherr S, Sessa C, Michelet R, Mc Laughlin AM, Hess D, Stathis A, Kloft C, Joerger M. Clinical Pharmacokinetics · Nov 2025 · doi: 10.1007/s40262-025-01588-z

2024

A model-informed clinical trial simulation tool with a graphical user interface for Duchenne muscular dystrophy. Kim J, Morales JF, Kang S, Klose M, Willcocks RJ, Daniels MJ, Belfiore-Oshan R, Walter GA, Rooney WD, Vandenborne K, Kim S. CPT: Pharmacometrics & Systems Pharmacology · Oct 2024 · doi: 10.1002/psp4.13246

Type 1 diabetes prevention clinical trial simulator: Case reports of model-informed drug development tool. Morales JF, Klose M, Hoffert Y, Podichetty JT, Burton J, Schmidt S, Romero K, O’Doherty I, Martin F, Campbell-Thompson M, Haller MJ, Atkinson MA, Kim S. CPT: Pharmacometrics & Systems Pharmacology · Jul 2024 · doi: 10.1002/psp4.13193

Population pharmacokinetics of TLD-1, a novel liposomal doxorubicin, in a phase I trial. Mc Laughlin AM, Hess D, Michelet R, Colombo I, Haefliger S, Bastian S, Rabaglio M, Schwitter M, Fischer S, Eckhardt K, Hayoz S, Kopp C, Klose M, Sessa C, Stathis A, Halbherr S, Huisinga W, Joerger M, Kloft C. Cancer Chemotherapy and Pharmacology · Jun 2024 · doi: 10.1007/s00280-024-04679-z

Exploring the impact of CYP2D6 and UGT2B7 gene-drug interactions, and CYP-mediated DDI on oxycodone and oxymorphone pharmacokinetics using physiologically-based pharmacokinetic modeling and simulation. Klose M, Cristofoletti R, Silva CM, Mangal N, Turgeon J, Michaud V, Lesko LJ, Schmidt S. European Journal of Pharmaceutical Sciences · Mar 2024 · doi: 10.1016/j.ejps.2023.106689

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). Colombo I, Koster KL, Holer L, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Eckhardt K, Hayoz S, Mc Laughlin AM, Kloft C, Klose M, Halbherr S, Baumgartner C, Sessa C, Stathis A, Hess D, Joerger M. European Journal of Cancer · Feb 2024 · doi: 10.1016/j.ejca.2024.113588

2021

Evaluation of the MeroRisk Calculator, A User-Friendly Tool to Predict the Risk of Meropenem Target Non-Attainment in Critically Ill Patients. Liebchen U, Klose M, Paal M, Vogeser M, Zoller M, Schroeder I, Schmitt L, Huisinga W, Michelet R, Zander J, Scharf C, Weinelt FA, Kloft C. Antibiotics · Apr 2021 · doi: 10.3390/antibiotics10040468

Abstracts/Posters

2026

Prior-fitted amortized generative neural networks models for population pharmacokinetics. Ojeda Marin CA, Sanchéz RJ, Hartung N, Huisinga W, Kumar P, Klose M, Jahn T, Faroughy DA. PAGE 2026 · Jun 2026 · Link

Prospective randomised controlled trial on model-informed precision dosing (MIPD) for ustekinumab and vedolizumab in inflammatory bowel diseases (MOVE-IT): A Bayesian framework incorporating parameter uncertainty. Widigson ESK, Braun K, Duvnjak Z, Klose M, Frimor C, Anilkumar K, Huisinga W, Steenholdt C, Ainsworth MA, Kloft C. PAGE 2026 · Jun 2026 · Link

Direct and hybrid machine learning approaches do not outperform NLME-based full Bayesian forecasting for early identification of delayed methotrexate elimination. Klose M, Marschner D, Knott M, Wendler J, Müller-Kühnle J, Nyhoegen C, Hartung N, Huisinga W, Michelet R, Mc Laughlin AM, Illerhaus G, Kloft C. PAGE 2026 · Jun 2026 · Link

2025

A Bayesian-NLME approach identifies patients at risk of delayed MTX elimination if informative TDM data is provided. Klose M, Marschner D, Knott M, Wendler J, Müller-Kühnle J, Kovar L, Huisinga W, Nyhoegen C, Michelet R, Mc Laughlin AM, Illerhaus G, Kloft C. PAGE 2025 · Jun 2025 · Link

TLD-1 – A novel liposomal doxorubicin formulation, in patients with advanced solid tumors: Final results of a multicenter, open-label, cross-over phase I study (SAKK 65/16). Joerger M, Klose M, Colombo I, Koster K, Gobat K, Haefliger S, Rabaglio M, Bastian S, Schwitter M, Eckhardt K, Hayoz S, Halbherr S, Sessa C, Michelet R, Mc Laughlin A, Hess D, Kloft C, Stathis A. ESMO TAT 2025 · Mar 2025 · Link

2024

Machine learning-driven flattening of model priors: A comparative simulation study across multiple compounds. Klose M, Thoma F, Kovar L, Huisinga W, Michelet R, Kloft C. PAGE 2024 · Jun 2024 · Link

2022

The Impact of UGT2B7 and CYP2D6 Gene-Drug- and CYP-mediated Drug-Drug-Interactions on Oxycodone and Oxymorphone Pharmacokinetics using PBPK Modelling. Klose M, Schmidt S, Cristofoletti R. ACoP13 · Oct 2022 · Link

2021

Using microdose-based activity measurement to individualise dosing of cytochrome P450 metabolised drugs: a case study with yohimbine and tamoxifen. Michelet R, Weinelt F, Klose M, Mc Laughlin AM, Kluwe F, Montefusco-Pereira C, Van Dyk M, Vay M, Huisinga W, Kloft C, Mikus G. PAGE 2021 · Sep 2021 · Link

Presentations

2026

Bringing quantitative approaches to the bedside: Forecasting the risk of delayed methotrexate elimination. Klose M. 15th Global Gators Symposium 2026 · Jun 2026 · Link