Thursday 16 October, 2025
Introduction: Now, more than ever, to increase drug success rate and accelerate clinical development, it is important to incorporate new…
Read morePoster: Study Design
A novel approach to evaluate the design of pediatric PK studies focused on accurate dose selection
Thursday 16 October, 2025
Objectives: A commonly used criterion to justify the design of a pediatric PK study is that the study must be…
Read moreDevelopment and evaluation of optimal 2×2 checkerboard designs for identification of pharmacodynamic drug interactions
Thursday 16 October, 2025
Objectives: In pharmacodynamic (PD) interaction screening elucidation of the nature of the PD interaction (synergy, antagonism, additivity) is essential. Checkerboard…
Read moreNew features in PFIM for optimal design in nonlinear mixed effects models using the S4 object system in R
Thursday 16 October, 2025
Introduction: Nonlinear mixed effects models (NLMEM) are widely used in model-based drug development to analyse longitudinal data. The use of…
Read morePharmacokinetics Optimization of Phase 2b/3 Study in Infants to Support the Development an RSV Monoclonal Antibody (MK-1654)
Thursday 16 October, 2025
Objectives: MK-1654 is a monoclonal antibody being developed for the prevention for Respiratory Syncytial Virus (RSV) in infants. A Phase…
Read moreDose optimization based on control and system theory: Case of Meropenem
Thursday 16 October, 2025
Objectives: Thanks to mathematical modeling, clinical pharmacology is an interesting and promising field of application of control and system theory…
Read moreComparison of study designs for multiple dose bioequivalence studies for long acting injections
Thursday 16 October, 2025
Introduction: Long-acting injections (LAIs) are extended-release formulations which reduce dosing frequency. Therefore, LAIs could be regarded as an alternative to…
Read moreThe use of optimal experimental design to inform a clinical trial on non-linearity of piperacillin clearance in critically ill patients.
Thursday 16 October, 2025
Objectives:Evidence on the linearity of piperacillin clearance at therapeutic plasma concentrations in patients in conflicting [1–5]. Non-linearity in piperacillin clearance…
Read morecontribution of trough concentration data for the evaluation of multiple-dose pharmacokinetics
Thursday 16 October, 2025
Objectives: In many clinical trial situations involving a multiple dose administration, the steady-state full pharmacokinetic (PK) study is emphasized to…
Read moreOptimal design of paediatric clinical trials: the Macitentan case study
Thursday 16 October, 2025
Introduction: This work is focused on the use of Modeling and Simulation (M&S) techniques to optimize experimental protocols of paediatric clinical…
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