Description

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.

Resources

Name	Format	Description	Link
Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/policy-pharmacometrics-drug-submissions-clinical-trials-applications.html
Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/produits-biologiques-radiopharmaceutiques-therapies-genetiques/information-demandes-presentations/lignes-directrices/politique-pharmacometrie-presentations-medicaments-demandes-essais-cliniques.html

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