Thursday 16 October, 2025
Objectives: The Drug Disease Model Resources (DDMoRe) Repository [1] is a powerful online tool for reference models storage [2]. It has…
Read morePoster: Methodology - Other topics
Correlative analysis of response to treatment and biomarker levels in a setting with a time-to-event efficacy outcome and sparse biomarker data
Thursday 16 October, 2025
Objectives: The identification of reliable pharmacodynamic markers of drug efficacy can be of great value, e.g. to explore optimal drug…
Read moreDose Finding in Clinical Development of 60 FDA-Approved Drugs Compared to the Learning versus Confirming Paradigm
Thursday 16 October, 2025
Introduction The highest prevailing reason for non-approval of new molecular entity (NME) applications by the US Food and Drug Administration…
Read moreUsing real world data to assess SGLT2 Inhibitor cardiovascular benefit and impacts of patient population characteristics
Thursday 16 October, 2025
Objectives: Following a successful cardiovascular (CV) outcome study EMPA-REG (1), SGLT2 inhibitor (SGLT2i) empagliflozin was approved for reducing the risk of…
Read moreInforming modeling and clinical trial simulation using the real world data: data content, quality and availability assessment
Thursday 16 October, 2025
Objectives: Model-informed drug discovery and development approaches are increasingly utilized and recognized in the pharmaceutical industry. Clinical trial simulations are essential…
Read moreA quantitative physiologic model of the interaction of nutrition and infection in determining the energy available for growth
Thursday 16 October, 2025
Objectives: To develop a quantitative physiologic model that represents the major causal dependencies relating nutritional status and enteric pathogen exposure…
Read moreNew information-theory-based methods in the analysis of childhood development data
Thursday 16 October, 2025
Background. The burden of childhood diarrhea and malnutrition remains high in South Asia due to inadequate household sanitation, lack of access…
Read moreReal World Evidence and Model-informed Drug Development – an antidiabetic drug cardiovascular outcome case study
Thursday 16 October, 2025
Objectives: Cardiovascular (CV) safety outcome study is routinely required in diabetes drug approval. Recent empagliflozin approval for CV indication provides…
Read moreSupervised item response theory modelling improves prediction of iatrogenic withdrawal in children
Thursday 16 October, 2025
Objectives: Item Response Theory (IRT) modelling is a multivariate data analysis technique, which is increasingly used in pharmacometrics to analyse…
Read moreEvaluating biosimilarity of monoclonal antibodies: comparison of population approach nonlinear mixed effects models to standard non-compartmental analysis
Thursday 16 October, 2025
Objectives: To study pharmacokinetic biosimilarity using full concentration-time profiles from a population pharmacokinetic analysis of 2 biotherapeutics (trastuzumab) and compare the…
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