Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS) Based Biowaivers
Data and Resources
Additional Info
| Field | Value |
|---|---|
| Source | |
| Version | None |
| Author | None |
| Author Email | None |
| Maintainer | None |
| Maintainer Email | None |
| Data Level | |
| Agreement Required | |
| Purpose Constraints | |
| Redistribution Allowed | |
| AI Training Allowed | |
| Data Steward | |
| Title (French) | Avis – Publication de l’ICH M9: Dispense de démonstration de bioéquivalence fondée sur le système de classification biopharmaceutique |
| Update Frequency | as_needed |
| Geographic Scope | [] |
| Criticality Level | [] |
| Sensitivity Level | unrestricted |
| Language | |
| Contact Person | |
| Contact Email | |
| Data Dictionary | |
| Open Canada Date Published | 2020-08-26 00:00:00 |
| Open Canada Date Modified | |
| Open Canada Subject | ["health_and_safety"] |
| Open Canada Keywords | {"fr": ["avis", "Conseil international pour l'harmonisation", "exigences techniques ICH", "lignes directrices M9", "ICH M9", "système de classification biopharmaceutique", "M9 BCS", "dispenses biologiques basées", "produits pharmaceutiques à usage humain"], "en": ["notice", "International Council for-Harmonisation", "ICH Technical Requirements", "guidance M9", "ICH M9", "biopharmaceutics classification system", "M9 BCS", "based biowaivers", "pharmaceuticals for human-use"]} |
| Open Canada Collection | publication |
| Principal Organization | |
| Reference Data | |
| Official Source |