The authors Pietro Laddomada and Marie Sylvianne Rabodoarivelo contributed equally to this work. Objectives: Phase IIa pulmonary tuberculosis (TB) trials…
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The Decision-Equivalence Metric (DEM) Method Based Evaluation of Biomarker Surrogacy in MASH
Objectives: Early and reliable go/no go decisions are essential for accelerating drug development in metabolic dysfunction–associated steatohepatitis (MASH). Surrogate biomarkers…
Read moreModel‑Informed Strategies for Methocarbamol Multi‑Particulate Regimen Development: Linking Mechanistic Modelling to Formulation Design Space
Objectives: Methocarbamol is a skeletal muscle relaxant that acts by inhibiting polysynaptic reflexes in the spinal cord and subcortical areas….
Read morePOPULATION PKPD AND EXPOSURE–RESPONSE ANALYSIS OF EPLONTERSEN SUPPORTS 45 MG SC Q4W WITHOUT DOSE ADJUSTMENT IN HEREDITARY TRANSTHYRETIN-MEDIATED POLYNEUROPATHY
Objectives To characterize the population PK (popPK), PKPD (popPKPD), and exposure–response (ER) relationships for efficacy and safety of eplontersen, supporting…
Read moreMechanistic modeling of the natural history of cancer progression and metastatic dissemination in stage I non-small cell lung cancer patients after curative surgery
Objectives Surgical resection is the standard of care for patients with early-stage non-small lung cancer (NSCLC)1. However, 5 to 10%…
Read moreAssessment of neural ODEs for modeling of longitudinal adverse events data and predictions of new treatment regimens
Objectives: Neural ODEs-based models [1] constitute a novel tool for PKPD modelling that utilize neural networks to describe longitudinal data…
Read moreLatent Neural-ODE for Model-Informed Precision Dosing: Overcoming Structural Assumptions in Pharmacokinetics
Introduction & Objectives Model-Informed Precision Dosing of drugs with a narrow therapeutic index, such as tacrolimus, routinely relies on estimating…
Read moreUse of a Clinical utility index to assess the opioid sparring effect between morphine and pregabalin and as aid in dose optimization.
Introduction: Chronic pain is a major burden for patients and is highly prevalent. In Europe and the US 21% and…
Read moreModel-Informed Precision Dosing of Cefepime: A Simulation Study Evaluating Target Attainment and Neurotoxicity Risk
Introduction: Cefepime is a broad-spectrum beta-lactam antibiotic critical for treating severe gram-negative infections, including Pseudomonas aeruginosa. Optimal dosing requires balancing…
Read moreGLOBAL VARIANCE-BASED SENSITIVITY ANALYSIS OF A PHARMACODYNAMIC MODEL FOR PIPERACILLIN/TAZOBACTAM TOWARDS OPTIMISED DOSING STRATEGIES
Introduction: The β-lactam/β-lactamase inhibitor combination piperacillin/tazobactam (PIP/TAZ) is a widely used empirical therapy in critical ill patients. The minimum inhibitory…
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