Oral: Other Topics

Explicit Optimization of Clinical Trials for Statistical Power

Thursday 16 October, 2025

Objectives: Optimal design (OD) theory as a tool to increase the efficiency of clinical studies, though theoretically well-established, still suffers from…

Read more

Limited sampling strategy for a population pharmacokinetic modelling of cocktail of phenotyping drugs

Thursday 16 October, 2025

Objectives: Cocktail approach using a combination of probes to phenotype several cytochromes P450 and transporters, is of high interest in…

Read more

Coupling complex mechanistic PK/PD modelling with dynamic system analysis to obtain relevant clinical/biological insights. Application to gonadotropin hormone release agonist

Thursday 16 October, 2025

Objectives:The gonadotropin hormone release agonist triptorelin (TPT) administered subcutaneously or intramuscularly in sustained release (SR) formulations is being used in…

Read more

A model of glucose clearance to improve the description of glucose homeostasis

Thursday 16 October, 2025

Objectives: Glucose homeostasis models have been developed as tools for the clinical development of glucose-lowering drugs [1]. The description of the…

Read more

Panel Discussion: Modelling and Simulation and the Regulatory Process

Thursday 16 October, 2025

This discussion will recapture a recent workshop at the EMA  (December 2011) and promote a future collaboration between modellers working…

Read more

Proposal for a Web-Based Open Pharmacometrics Curriculum

Thursday 16 October, 2025

Objectives: Given the small number of formal academic training programs and associated faculty, resource sharing and collaboration in pharmacometrics (PM) training…

Read more

The Role of Model Based Drug Development – Is it time to repaint the canvas?

Thursday 16 October, 2025

Drug development and regulatory decisions are driven by information that is compiled primarily from clinical trials and other supportive experiments,…

Read more

Application relevant shrinkage metrics

Thursday 16 October, 2025

Background: There is a general concern that high η-shrinkage [1] may bias applications such as sequential PKPD analysis and sub-group…

Read more

Considerations when deriving time-averaged exposure for censored subjects for logistic regression exposure-response analyses

Thursday 16 October, 2025

Objectives: Exposure-response (ER) analyses are routinely performed as part of model-informed drug development to evaluate the risk-to-benefit ratio for dose…

Read more

Scaling pharmacokinetics to estimate the “first dose in children”: comparing allometric scaling and PBPK

Thursday 16 October, 2025

Introduction: For the estimation of “first dose in children” scaling of the pharmacokinetics (PK) from adults to children is required. Two…

Read more