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Enseignants
. SOMEBODY; Elens Laure (coordinateur(trice));
Langue
d'enseignement
d'enseignement
Anglais
Thèmes abordés
This course on simulation covers various types of simulations, including deterministic and probabilistic approaches, and addresses parameter uncertainty. It explores practical, technical, and clinical aspects related to simulation outcomes, guiding students from initial questions to clinical solutions. The course includes creating virtual patient datasets, clinical trial simulations, model-based meta-analysis, designing first-in-human (FIH) studies, and power calculations. It emphasizes decision-making using simulation results for drug development, repurposing, and precision dosing, and provides insights into reporting simulation results and using simulation software tools.
Contenu
The aim of this course is to gain proficiency in understanding the theory and hands-on expertise in the application of nonlinear mixed-effects models for simulations to inform trial design, drug development, drug repurposing, dose finding, and personalized medicine (including precision dosing). Furthermore, students will learn how to communicate simulation results effectively.
- Simulation
- Clinical trial simulation
- Model-informed drug development
- Model-informed drug repurposing
- Model-informed precision dosing
- Hands-on exercises
- Industry experience
- Regulatory perspective
- Hospital experience
Méthodes d'enseignement
Lectures
Hands on
Seminars
Hands on
Seminars
Modes d'évaluation
des acquis des étudiants
des acquis des étudiants
Type: Exam during the examination period
Assessment method: Oral, Practical exam, Written
The evaluation is based on a team project, for which a report will be prepared, to be submitted before the oral exam.
The oral exam will take place during the examination period. At the oral exam, students will individually present and defend their project. Questions will be asked for clarification about techniques used, statements made, and conclusions drawn in the report and presentation.
Project: max. score 8/20
Oral exam: max. score 12/20
The project counts for the full 8 points only if at least 6/12 is obtained on the oral exam.
In case the score on the oral exam is less than 6/12, the score on the report is reduced to at most 4/8. If the score for the oral part is less than 3/12, the score for the report is reduced to at most 2/8. This is to encourage active participation in the teamwork.
Timely submission of the report is a necessary condition to take part in the exam.
In case the deadline has not been met, the score for this course will be NA.
Assessment method: Oral, Practical exam, Written
The evaluation is based on a team project, for which a report will be prepared, to be submitted before the oral exam.
The oral exam will take place during the examination period. At the oral exam, students will individually present and defend their project. Questions will be asked for clarification about techniques used, statements made, and conclusions drawn in the report and presentation.
Project: max. score 8/20
Oral exam: max. score 12/20
The project counts for the full 8 points only if at least 6/12 is obtained on the oral exam.
In case the score on the oral exam is less than 6/12, the score on the report is reduced to at most 4/8. If the score for the oral part is less than 3/12, the score for the report is reduced to at most 2/8. This is to encourage active participation in the teamwork.
Timely submission of the report is a necessary condition to take part in the exam.
In case the deadline has not been met, the score for this course will be NA.
Autres infos
KULeuven course K0P04A
Ressources
en ligne
en ligne
Slide decks on Toledo
Support de cours
- Slide decks on Toledo
- Video recorded lectures
- selected publications
- Model codes
Faculté ou entité
en charge
en charge
Programmes / formations proposant cette unité d'enseignement (UE)
Intitulé du programme
Sigle
Crédits
Prérequis
Acquis
d'apprentissage
d'apprentissage
Advanced master in pharmacometrics