Poster: Methodology - Covariate/Variability Models

Application of different approaches to generate virtual patient populations for QSP model of Physiologically based pharmacokinetic model of anti-PD-1 therapeutic antibodies

Thursday 16 October, 2025

Introduction: Conventional approach of QSP modelling includes the procedure of fitting of a model output to series of mean data…

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Bridging studies: handling covariates models using the Prior approach

Thursday 16 October, 2025

Introduction/Objectives: The PRIOR function in NONMEM stabilizes model estimates toward prior estimates by adding a penalty function on the objective…

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Implementation of event time distribution as a random effect in time-to-event analysis

Thursday 16 October, 2025

Introduction: Different distributions of event times considered in time-to-event (TTE) analysis are well documented. These distributions include the exponential, Weibull,…

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Model-based Allometric Scaling Approaches for Predicting Human Pharmacokinetics of CB 4332, a Therapeutic Complement Factor I Protein

Thursday 16 October, 2025

Introduction: Initial dose selection in first-in-man studies relies on extrapolation of animal drug exposure and drug safety. It is well-established…

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Population pharmacokinetic analysis on data from a bioequivalence study – Effects of hormonal contraceptives on drug exposure

Thursday 16 October, 2025

Introduction: The application of population pharmacokinetics (PopPK) modelling to data from bioequivalence studies can provide valuable insight on the pharmacokinetics…

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Understanding sources of variability: The variability attribution plot

Thursday 16 October, 2025

Objectives: Understanding and explaining sources of variability in the data is a significant component of any analysis. Clinical trial data…

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Use of a multivariate distribution to simulate severe renal impaired patients

Thursday 16 October, 2025

Objectives: Specific studies with renal impaired (RI) patients are usually carried out for drug exposure assessment in this special population. Patient…

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Linearization of full random effects modeling (FREM) for time-efficient automatic covariate assessment

Thursday 16 October, 2025

Objectives: Full Random Effects Modeling (FREM) is a methodology for covariate modeling whereupon a covariate set of interest is prespecified…

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Practical considerations for using the full random effects modeling (FREM) approach to covariate modeling

Thursday 16 October, 2025

Objectives: The FREM approach to covariate modeling has been suggested to avoid issues with standard covariate model building approaches, e.g. selection…

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Pharmacokinetics of vancomycin in intensive-care patients

Thursday 16 October, 2025

Objectives: Vancomycin has been used and still is being used as an effective antibiotic. Nevertheless, there is still a need…

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