Jeroen V. Koomen

Model‐Informed Approaches for Pediatric Type 2 Diabetes Evidence Generation: Insights from a Model‐Based Longitudinal HbA1c Meta‐Analysis from EMA Marketing Authorization Applications

Pieter Colin, Efthymios Manolis, Jeroen V. Koomen

Evidence generation for antihyperglycemic therapies in pediatric type 2 diabetes mellitus (T2DM) remains challenging, with most randomized trials failing to demonstrate statistically significant reductions in glycated hemoglobin (HbA1c), partly due to substantial between-subject variability. To better understand the sources and implications of …

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Should a pharmacokinetic model be more than its data?

Loes Maton, Beatrijs I. Valk, Michel Struys, Jeroen V. Koomen et autres

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OpenPMX Software for Nonlinear Mixed‐Effect Models in Pharmacometrics: Precision Compared With NONMEM First‐Order Conditional Estimation

Douglas J. Eleveld, Jeroen V. Koomen, Jasper Stevens, Pieter Colin et autres

Mixed effects models are a backbone of pharmacometrics, and NONMEM software, with the first-order conditional method with interaction having become the de facto industry standard for model estimation. Documentation exists for the general mathematical methodology for estimation, but many technical and implementation …

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Evaluating Model‐Based Extrapolation of Plasma Exposure for Long‐Acting Injectable Products: From Single‐ to Multiple‐Dose Trials

D. Esther Lubberts, Douglas J. Eleveld, Laurens F. M. Verscheijden, Pieter Colin et autres

Long-acting injectable medicinal products (LAIs) prolong drug release and thereby aim to enhance adherence and patient outcomes. European regulatory guidelines require the conduct of single- and multiple-dose trials to exclude differences in drug release between non-steady and steady state conditions. The complexity …

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Target controlled infusion in the intensive care unit: a scoping review

Michele Introna, Carla Carozzi, Andrea Gentile, Riccarda Girasole et autres

Target-controlled infusion (TCI) systems, originally developed for intravenous drug administration of anesthetic drugs, enable precise drug delivery based on pharmacokinetic-pharmacodynamic (PKPD) models. While widely used in the operating room, their application in the intensive care unit (ICU) remains limited despite the complexity …

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A Population Pharmacokinetic Analysis for Piperacillin/Tazobactam in Patients with End-Stage Kidney Disease Undergoing Intermittent Haemodialysis: Extension of a General-Purpose Model

Jeroen V. Koomen, Floris Vanommeslaeghe, Sigurd Delanghe, Wim Van Biesen et autres

BACKGROUND AND OBJECTIVE: End-stage kidney disease (ESKD) patients undergoing haemodialysis (HD) require a dosing regimen that balances the low endogenous clearance with the additional dialyser clearance. This study aimed to expand a previously proposed general-purpose pharmacokinetic model for piperacillin/tazobactam with a new …

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Pharmacokinetics and Pharmacodynamics of Remimazolam for Procedural Sedation in Children and Adolescents

Pieter Colin, Lynn H. Bichajian, Valentin Curt, Jeroen V. Koomen et autres

BACKGROUND: Remimazolam is not approved for use in pediatric patients. The pharmacokinetics of remimazolam have been reported to be similar to those of adult patients after scaling for body size. This article reports on the pharmacokinetics and pharmacodynamics of pediatric patients aged …

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Development and analysis of a remimazolam pharmacokinetics and pharmacodynamics model with proposed dosing and concentrations for anaesthesia and sedation

Douglas J. Eleveld, Pieter Colin, Johannes P. van den Berg, Jeroen V. Koomen et autres

BACKGROUND: Pharmacokinetic-pharmacodynamic (PK-PD) models of remimazolam and their covariate relationships are useful for understanding drug disposition and predicting drug effects. Although clinical studies have shown that remimazolam induction doses decline with advancing age, this property is not reflected in existing models. The …

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A review on the role of extrapolation as basis for paediatric marketing authorization applications of medicines in the EU

Charlotte W. M. Simons, Maaike van Dartel, Michiel van den Heuvel, Loes den Otter et autres

AIMS: For new medicines, drug companies obtain regulatory approval on the strategy to generate evidence in the paediatric population, which can be supported by extrapolation of evidence obtained in a reference population. This study investigated whether paediatric marketing authorization applications (PMAAs) supported …

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Influence of Remifentanil on the Pharmacokinetics and Pharmacodynamics of Remimazolam in Healthy Volunteers

Remco Vellinga, Jeroen V. Koomen, Douglas J. Eleveld, Thomas Stöhr et autres

BACKGROUND: Synergistic effects between opioids and remimazolam on Bispectral Index (BIS) and Modified Observer's Assessment of Alertness and Sedation (MOAAS) score were previously described. This study aimed to characterize the influence of remifentanil on the sedative properties of remimazolam as measured by …

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A Pooled Pharmacokinetic Analysis for Piperacillin/Tazobactam Across Different Patient Populations: From Premature Infants to the Elderly

Daming Kong, Jason A. Roberts, Jeffrey Lipman, Fabio Silvio Taccone et autres

The pharmacokinetics (PK) of piperacillin/tazobactam (PIP/TAZ) is highly variable across different patient populations and there are controversies regarding non-linear elimination as well as the fraction unbound of PIP ( f UNB_PIP ). This has led to a plethora of subgroup-specific models, increasing …

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Population Pharmacokinetic Modelling of Norepinephrine in Healthy Volunteers Prior to and During General Anesthesia

Yingxue Li, Jeroen V. Koomen, Douglas J. Eleveld, Johannes P. van den Berg et autres

Intraoperation hypotension (IOH) is commonly observed in patients undergoing surgery under general anesthesia, and even a brief episode of IOH can lead to unfavorable outcomes. To reduce the risk, blood pressure is closely measured during general anesthesia, and norepinephrine (NE) is frequently …

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