Thursday 7 May, 2026
Objectives Several monoclonal antibodies (mAbs) are currently licensed for the treatment of severe eosinophilic asthma. Reslizumab and mepolizumab target IL-5,…
Read morePoster: Methodology - Study Design
Model-Informed Biosimilar Study Design Under Evolving Regulatory Guidance: Dose Selection and Power Optimization in Pegfilgrastim
Thursday 7 May, 2026
INTRODUCTION The FDA’s October 2025 draft update to Scientific Considerations in Demonstrating Biosimilarity marks a significant evolution in biosimilar development….
Read morePaediatric pharmacokinetic studies could be optimized for the precision of the clinically relevant exposure endpoint instead of PK parameter precision
Thursday 7 May, 2026
Introduction: During drug development, sponsors are generally required to study their drug candidate in children. Sometimes the drug’s benefit-risk balance…
Read moreAPPLICATION OF CONTINUOUS-CATEGORICAL IRT MODELLING TO ENHANCE STATISTICAL POWER IN N-OF-1 TRIALS: SIMULATION-BASED EVALUATION
Thursday 7 May, 2026
Background The rapid development of personalized disease-modifying therapies, such as antisense oligonucleotides, has outpaced the evolution of the clinical trials…
Read moreAdvancing sample size justifications in confirmatory paediatric exposure-matching trials submitted to regulatory authorities: a benchmarking analysis and novel methodological framework.
Thursday 7 May, 2026
Introduction: Generation of evidence in the paediatric population is often hampered by difficulties in conducting clinical trials [1]. Extrapolation of…
Read moreAssessment of Sample Size Allocation for A Multi-regional Phase 2 Trial: Comparison of Statistical and Dose-Exposure-Response (D-E-R) Approaches
Thursday 16 October, 2025
Introduction: Global simultaneous drug development has become a common practice in multinational pharmaceutical companies to reduce the time lag to…
Read moreUnlocking efficiency in dose selection based on pharmacokinetic-pharmacodynamic modeling of tumor size data: Insights from Clinical Trial Simulations
Thursday 16 October, 2025
Objectives: Dose optimization is a critical objective of early clinical development of oncology drugs. The value of longitudinal tumor size…
Read moreA comparative analysis of Bayesian dose-finding designs incorporating pharmacokinetics information
Thursday 16 October, 2025
Introduction: In most Phase I and Phase I/II studies in patients, dose-finding and pharmacokinetics/pharmacodynamics (PK/PD) are still analyzed separately [1]….
Read moreModelling framework to simulate phenotypic results of antiviral PROTACs
Thursday 16 October, 2025
Objectives: Proteolysis-targeting chimeras (PROTAC) are novel chemical concepts taking advantage of the proteasome to degrade target proteins. Compared to PROTACs…
Read moreIndividualized tacrolimus dosing in pediatric kidney transplantation: development of PBPK-based predictive models, simulations and applications (ModSimTer-Tacro Study)
Thursday 16 October, 2025
Objectives: Development of individual dosage (ID) methods is a long-standing goal pursued by clinicians. Therapeutic individualization requires processing a significant…
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