Thursday 16 October, 2025
Objectives: Optimal design in population PKPD is based on prior information on the models and parameters. Adaptive designs [1,2] are…
Read morePoster: Methodology - Study Design
Longitudinal dose-response modelling as primary analysis of a clinical study
Thursday 16 October, 2025
Objectives: ANOVA or analysis of covariance (ANCOVA) is commonly used as the primary analysis for clinical studies. For study designs…
Read moreAdaptive optimal design for the concentration tiers in time-kill curve experiments.
Thursday 16 October, 2025
Objectives: In time-kill curve (TKC) modelling, precise estimation of PD parameters is crucial, e.g. to perform reliable simulations. Conventional designs…
Read moreStatistical Power Analysis to Detect Drug-Drug Interaction between Lorezapam and Probenecid in Healthy and Renal-impaired Populations Using PBPK Modelling and the Simcyp R Package
Thursday 16 October, 2025
Objectives: A tool is already available within the Simcyp Simultaor to calculate the power of studies to correctly detect the difference…
Read moreOptimized Reduced Designs of Pharmacokinetic Clinical Trials Utilizing Target Mediated Drug Disposition Models
Thursday 16 October, 2025
Objectives: Monoclonal antibodies (mAbs) may display target mediated drug disposition (TMDD) [1] when target binding notably alters the disposition of the…
Read moreApplication of Model-Based Adaptive Optimal Design to determine a recommended dosing regimen for combination therapy in oncology
Thursday 16 October, 2025
Objectives: Phase 1 trials in the context of combination therapy is a complex question differing from the case of single therapy….
Read moreModel-based comparison of alternative study designs in paediatric trials
Thursday 16 October, 2025
Objectives: The adoption of alternative designs can potentially facilitate the realization of paediatric trials, especially when compared to the standard practice….
Read morePerformance of composite and serial study designs for estimation of toxicokinetic parameters.
Thursday 16 October, 2025
Objectives: In rodent studies, microsampling offers opportunity to sample main study animals for toxicokinetic (TK) assessment rather than satellite animals. …
Read moreSynthesising pragmatic and optimal design: NAPPA – a paediatric penicillin population pharmacokinetic study
Thursday 16 October, 2025
Objectives: The Neonatal and Paediatric Pharmacokinetics (PK) of Antimicrobials study, NAPPA, is a multicentre population PK study evaluating six penicillins…
Read moreConcentration-QTc analysis versus Intersection Union Test: sample size considerations for a thorough QT study
Thursday 16 October, 2025
Objectives: Dedicated Thorough QT (TQT) studies are conducted to assess the proarrhythmic potential of non-antiarrhythmic drugs based on evaluating the…
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