Thursday 16 October, 2025
Objectives: In dose-response studies with censored time-to-event outcomes, D-optimal designs depend on the true model parameters and the amount of…
Read morePoster: Methodology - Study Design
Clinical Trial Simulations to Assess the Probability of Revealing Biomarker Dose-Response in Ph1 Trials
Thursday 16 October, 2025
Objectives: For rational dose selection of targeted anticancer agents, it is critical to obtain early assessment of clinical activity and…
Read moreSimulation of Scanning Time Point Selection for PET Scan Studies in Clinical Development of CNS Drugs: A Simple Fixed-time Design is Recommended over Scattered-time Point Designs
Thursday 16 October, 2025
Objectives: PET is a tool frequently used to characterize the PK-PD relationship of plasma drug concentration and receptor occupancy in the…
Read moreEarly phase dose-finding designs for bridging studies in pediatrics
Thursday 16 October, 2025
Objectives: Dose-finding (DF) studies are challenging to calibrate, particularly in a paediatric population. Settings are usually chosen by usage or…
Read moreClinical Trial Simulation of a Phase I Paediatric Oncology Study using Simulo
Thursday 16 October, 2025
Introduction: The main challenge during oncology drug development in the paediatric population is to improve the clinical development process making…
Read moreClinical trial optimization of efficacy studies in slowly progressive diseases
Thursday 16 October, 2025
Objectives: Treatments in slowly progressive diseases, such as Parkinson’s or Alzheimer’s disease, fall into two categories. Symptomatic treatment will treat…
Read moreReal-world data can estimate pre-exposure prophylactic drug effect in community-acquired respiratory infection trials
Thursday 16 October, 2025
Introduction Influenza pre-exposure prophylaxis (PrEP) drugs protect by ensuring efficacious drug concentrations at time of viral entry to inhibit virus…
Read moreDesign of preclinical experiments: an example in chemotherapy-induced myelosupression
Thursday 16 October, 2025
Objectives: To investigate a new preclinical study design (referred to as a compact design) that removes the need for satellite…
Read moreModel-based optimal robust design in pharmacometrics
Thursday 16 October, 2025
Objectives: Optimal design requires prior information on models and parameters, which may be difficult to guess. Robust design approaches have…
Read moreOptimal design for informative protocols in xenograft tumor growth inhibition models
Thursday 16 October, 2025
Objectives: The in vivo evaluation of antitumor effect is an important step of the preclinical drug development. Xenograft experiments are…
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