Introduction: Conventional approach of QSP modelling includes the procedure of fitting of a model output to series of mean data…
Read morePoster: Methodology - Covariate/Variability Models
Bridging studies: handling covariates models using the Prior approach
Introduction/Objectives: The PRIOR function in NONMEM stabilizes model estimates toward prior estimates by adding a penalty function on the objective…
Read moreImplementation of event time distribution as a random effect in time-to-event analysis
Introduction: Different distributions of event times considered in time-to-event (TTE) analysis are well documented. These distributions include the exponential, Weibull,…
Read moreModel-based Allometric Scaling Approaches for Predicting Human Pharmacokinetics of CB 4332, a Therapeutic Complement Factor I Protein
Introduction: Initial dose selection in first-in-man studies relies on extrapolation of animal drug exposure and drug safety. It is well-established…
Read morePopulation pharmacokinetic analysis on data from a bioequivalence study – Effects of hormonal contraceptives on drug exposure
Introduction: The application of population pharmacokinetics (PopPK) modelling to data from bioequivalence studies can provide valuable insight on the pharmacokinetics…
Read moreUnderstanding sources of variability: The variability attribution plot
Objectives: Understanding and explaining sources of variability in the data is a significant component of any analysis. Clinical trial data…
Read moreUse of a multivariate distribution to simulate severe renal impaired patients
Objectives: Specific studies with renal impaired (RI) patients are usually carried out for drug exposure assessment in this special population. Patient…
Read moreLinearization of full random effects modeling (FREM) for time-efficient automatic covariate assessment
Objectives: Full Random Effects Modeling (FREM) is a methodology for covariate modeling whereupon a covariate set of interest is prespecified…
Read morePractical considerations for using the full random effects modeling (FREM) approach to covariate modeling
Objectives: The FREM approach to covariate modeling has been suggested to avoid issues with standard covariate model building approaches, e.g. selection…
Read morePharmacokinetics of vancomycin in intensive-care patients
Objectives: Vancomycin has been used and still is being used as an effective antibiotic. Nevertheless, there is still a need…
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