Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications

Pharmacometrics is the science of using quantitative analysis and modelling and simulation (M&S) approaches to inform and enhance drug development and regulatory review. Pharmacometrics also encompasses quantitative system pharmacology and model-informed drug development (MIDD) approaches.

Data and Resources

Additional Info

Field Value
Source
Version
Author
Author Email
Maintainer
Maintainer Email
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Énoncé de politique : Utilisation de la pharmacométrie dans les présentations de médicaments et les demandes d'essais cliniques
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published 2021-03-31 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["pharmacométrie", "présentations de médicaments", "demandes d'essais cliniques", "analyse quantitative", "approches de modélisation-simulation", "pharmacologie systémique quantitative", "approches de développement de médicaments fondées sur des modèles"], "en": ["pharmacometrics", "drug submissions", "clinical trial applications", "quantitative analysis", "modelling-simulation approaches", "quantitative system pharmacology", "model-informed drug-development approaches"]}
Open Canada Collection publication
Principal Organization
Reference Data
Official Source