Guidance Document: Tamper-resistance Formulations of Opioid Drug Products

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when sponsors seek to obtain approval for controlled-release opioid drug formulations with tamper-resistant properties and wish to include, in product monographs, scientific statements and claims regarding tamper-resistance.

Données et ressources

Info additionnelle

Champ Valeur
Source
Version
Producteur
Courriel de l'auteur
Mainteneur
Courriel du mainteneur
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Ligne directrice : Propriétés de résistance à l'altération de produits pharmaceutiques opioïdes
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
Langue
Contact Person
Contact Email
Dictionnaire de données
Open Canada Date Published 2017-05-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["document d'orientation", "formulations inviolables", "médicament opioïde", "inviolabilité", "produits opioïdes à libération contrôlée", "pré-commercialisation", "présentations de drogue"], "en": ["guidance document", "tamper-resistance formulations", "opioid drug", "tamper-resistance", "controlled-release opioid products", "pre-market", "drug submissions"]}
Open Canada Collection publication
Principal Organization
Reference Data
Official Source