Poster: Methodology - Study Design

Evaluation of tumor kinetics metrics as early endpoint to support decision making in early drug development

Thursday 16 October, 2025

Objectives: In the process of drug development in oncology, moving from early to late phase is a critical and complex step….

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PFIM 4.0: new features for optimal design in nonlinear mixed effects models using R

Thursday 16 October, 2025

Objectives: To extend PFIM, the only tool for population optimal design in R, with several new features.  Methods: Model based…

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PK/PD modelling: a usefull tool to train people to better design in vivo chronic study in ob/ob mice

Thursday 16 October, 2025

Objectives: In preclinical research, pharmacokinetic/pharmacodynamic (PK/PD) studies are very often not enough discussed between pharmacologists and modellers before the pivotal in…

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Model-based simulation assessment of Personalized Healthcare strategies. A case for siponimod in multiple sclerosis.

Thursday 16 October, 2025

Objectives: The “One dose fits all” concept still dominates in clinical development. Pharmacometrics could definitely contribute to implement Personalized Healthcare…

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Population PKPD analysis of preclinical data to inform clinical study design for a platelet derived hemostatic agent

Thursday 16 October, 2025

Objectives: This work aimed to utilize population pharmacokinetic-pharmacodynamic (PKPD) modeling to support the development of a novel platelet-derived hemostatic agent,…

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Towards the Best Practices to Create Virtual Healthy Control Populations for Organ Impairment Studies

Thursday 16 October, 2025

Introduction: Organ impairment pharmacokinetic (PK) studies typically require a healthy control group. However, enrolling healthy participants in clinical studies raises…

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InSilicoTrials’ Clinical Trial Simulator for Optimizing Oncology Study Designs, Trastuzumab Emtansine (T-DM1) Adaptive Dosing Case Example

Thursday 16 October, 2025

Objectives: This work aims to illustrate the value of using InSilicoTrial’s clinical trial simulator for optimizing oncology study designs, using…

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Evaluating the impact of treatment discontinuation on the outcome of clinical trials for weight management: A simulation study

Thursday 16 October, 2025

Introduction. Obesity presents a major challenge to global public health with an estimated global prevalence of nearly 20% by 2030…

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mlxDesignEval: A novel R package for design evaluation based on MonolixSuite, and its comparison to popED and PFIM

Thursday 16 October, 2025

Introduction: When clinical trial data is used to fit population PK/PD models, one may design the trial to optimize the…

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Predictive Probability of Success (PPOS) in Longitudinal Endpoint to Predict Trial Outcome: What can we learn from a retrospective interim analysis?

Thursday 16 October, 2025

Background: Clinical trials require significant resources (subjects, time and money) and often fail in achieving their objectives. Predicting the final…

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