Objectives: In the process of drug development in oncology, moving from early to late phase is a critical and complex step….
Read morePoster: Methodology - Study Design
PFIM 4.0: new features for optimal design in nonlinear mixed effects models using R
Objectives: To extend PFIM, the only tool for population optimal design in R, with several new features. Methods: Model based…
Read morePK/PD modelling: a usefull tool to train people to better design in vivo chronic study in ob/ob mice
Objectives: In preclinical research, pharmacokinetic/pharmacodynamic (PK/PD) studies are very often not enough discussed between pharmacologists and modellers before the pivotal in…
Read moreModel-based simulation assessment of Personalized Healthcare strategies. A case for siponimod in multiple sclerosis.
Objectives: The “One dose fits all” concept still dominates in clinical development. Pharmacometrics could definitely contribute to implement Personalized Healthcare…
Read morePopulation PKPD analysis of preclinical data to inform clinical study design for a platelet derived hemostatic agent
Objectives: This work aimed to utilize population pharmacokinetic-pharmacodynamic (PKPD) modeling to support the development of a novel platelet-derived hemostatic agent,…
Read moreTowards the Best Practices to Create Virtual Healthy Control Populations for Organ Impairment Studies
Introduction: Organ impairment pharmacokinetic (PK) studies typically require a healthy control group. However, enrolling healthy participants in clinical studies raises…
Read moreInSilicoTrials’ Clinical Trial Simulator for Optimizing Oncology Study Designs, Trastuzumab Emtansine (T-DM1) Adaptive Dosing Case Example
Objectives: This work aims to illustrate the value of using InSilicoTrial’s clinical trial simulator for optimizing oncology study designs, using…
Read moreEvaluating the impact of treatment discontinuation on the outcome of clinical trials for weight management: A simulation study
Introduction. Obesity presents a major challenge to global public health with an estimated global prevalence of nearly 20% by 2030…
Read moremlxDesignEval: A novel R package for design evaluation based on MonolixSuite, and its comparison to popED and PFIM
Introduction: When clinical trial data is used to fit population PK/PD models, one may design the trial to optimize the…
Read morePredictive Probability of Success (PPOS) in Longitudinal Endpoint to Predict Trial Outcome: What can we learn from a retrospective interim analysis?
Background: Clinical trials require significant resources (subjects, time and money) and often fail in achieving their objectives. Predicting the final…
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