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 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 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…
Read moreEvaluation of study designs to test the intact nephron hypothesis
Thursday 16 October, 2025
Background: Methods to adjust doses of drugs that are renally cleared are based on the assumption of a linear relationship…
Read moreModel based support to biosimilarity assessment planning – A case study of pegfilgrastim
Thursday 16 October, 2025
Introduction/Objectives Pegfilgrastim (PG) is a recombinant pegylated granulocyte colony stimulating factor (GCSF) used in the treatment of chemotherapy induced neutropenia…
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