Objectives: Electroencephalography (EEG)-derived indices are widely used to titrate volatile anesthetics, yet pharmacodynamic (PD) characterization and head-to-head comparisons for newer…
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IMMORTAL TIME BIAS IN USING IMMUNE-MEDIATED ADVERSE EVENTS AS PREDICTORS OF SURVIVAL: INSIGHTS FROM A MULTISTATE MODELING APPROACH
Objectives: Immune-mediated adverse events (IMAE) have been suggested as prognostic factors for progression-free survival (PFS) and overall survival (OS) in…
Read moreMissing data imputation for aggregate covariates of patient characteristics in model-based meta-analysis
Objectives Model-based meta-analysis (MBMA) integrates data across clinical trials to estimate treatment effects. Including summary-level patient characteristics (covariates) can explain…
Read moreINFLUENCE OF NON-ADHERENCE ON THE ESTIMATION OF PHARMACOKINETIC PARAMETERS OF CABOZANTINIB IN RENAL CELL CARCINOMA
INTRODUCTION Oral anticancer drugs (OADs) play a vital role in modern cancer therapy. However, they require a high degree of…
Read moreSex differences in sunitinib tolerability and patient-reported outcomes in metastatic renal cell carcinoma: the role of exposure and implications for precision dosing
Objectives Biological sex contributes to variability in sunitinib pharmacokinetics, but the implications for tolerability, treatment modifications, and patient-reported side-effect burden…
Read moreQUANTITATIVE SYSTEMS PHARMACOLOGY GUIDED MABEL ESTIMATION FOR T-CELL ENGAGERS (TCE): A CASE STUDY TO SUPPORT MODEL-INFORMED FIRST-IN-HUMAN DOSE SELECTION
OBJECTIVES CD3 T-cell engagers (TCEs) pose a significant risk of cytokine release syndrome (CRS), making accurate first-in-human (FIH) dose selection…
Read moreCancer-Driven Changes in Small Intestinal and Colonic Drug-Metabolising Enzymes and Transporters: Updating Cancer Populations for PBPK Modelling and Pharmacokinetic Implications
Objectives Small intestine cancer is rare, with a steady rise over the last decades. Because of its rarity, clinical trials…
Read moreR-based Bayesian workflow for ODE pharmacometrics modeling: generalized dapagliflozin PK model as a case study
Introduction Most model-based analyses in pharmacometrics (PMx) and the associated statistical inference follow the frequentist paradigm, established in the early…
Read moreA physiologically-based pharmacokinetic model for intraperitoneal irinotecan to evaluate the impact of UGT1A1 variability on SN-38 exposure
Objectives Intraperitoneal (IP) irinotecan is currently being investigated for treatment of peritoneal metastases, to overcome limited IP drug availability associated…
Read moreFROM CAPILLARY TO CLINIC: MODEL-BASED TRANSLATION OF VOLUMETRIC ABSORPTIVE MICROSAMPLING CONCENTRATIONS FOR THERAPEUTIC DRUG MONITORING OF CABOZANTINIB
Objective:Substantial interindividual pharmacokinetic variability results in up to 45% of patients receiving oral anticancer drugs being under- or overexposed[1]. Therapeutic…
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