Thursday 16 October, 2025
Objectives: Nonlinear mixed effect models (NLMEMs) are widely used for the analysis of longitudinal data obtained during clinical trials. An…
Read morePoster: Methodology - Study Design
Characterisation of time course of response using model based meta-analysis of public domain data to support trial design in axial spondyloarthritis
Thursday 16 October, 2025
Objectives: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterised by inflammation of the sacroiliac joints and spine. Clinical response…
Read morePower calculation methods to detect covariates effect when combining observed and simulated data.
Thursday 16 October, 2025
Objectives: Monte Carlo Mapped Power (MCMP) has been developed as an alternative rapid method [1] with respect to stochastic simulation…
Read moreUsing Hamiltonian Monte-Carlo to design longitudinal count studies accounting for parameter and model uncertainties
Thursday 16 October, 2025
Objectives: Nonlinear mixed effect models (NLMEM) are widely used for the analysis of longitudinal data. To design these studies, optimal…
Read moreClinical trial simulations to optimize dose finding studies in paediatric oncology
Thursday 16 October, 2025
Objectives: Paediatric dose finding studies are challenging to perform due to ethical reasons, the limited number of available patients and…
Read moreProgram-wise trial simulation assessing design and analysis options from proof of concept to dose ranging
Thursday 16 October, 2025
Objectives: Getting the right dose(s) for Phase 3 program and market authorization is considered as one of the most difficult…
Read moreUse of interim analysis to improve efficiency of clinical trial simulations in treatment comparison trial design studies
Thursday 16 October, 2025
Objectives: Clinical trial simulation (CTS) using Monte Carlo (MC) technique has been increasingly used in pharmaceutical industry to make drug…
Read morePrediction of subtherapeutic tigecycline plasma levels by model-based Bayesian individualization
Thursday 16 October, 2025
Objectives: To investigate the optimal sampling times for estimating posthoc clearance of tigecycline and assess their performance, in terms of predicting…
Read moreAdaptive designs for dose finding clinical trials with time-to-event outcomes
Thursday 16 October, 2025
Objectives: Many clinical trials use time-to-event (TTE) outcomes as primary measures of efficacy or safety. For instance, in dose finding cancer…
Read morePK/PD modeling of recurrent events and clinical trial simulation in optimizing Phase 3 dose selection
Thursday 16 October, 2025
Objectives: Dose selection for confirmative Phase 3 studies is always considered as one of the most difficult tasks in drug…
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