Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (i.e., new drug and abbreviated new drug submissions), of proposed modifications to Health Canada’s comparative bioavailability requirements when multiphasic plasma concentration profiles have been demonstrated to be integral to the product’s therapeutic effect.

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Champ	Valeur
Dernière modification	avril 17, 2026, 22:01 (TU)
Créé le	avril 17, 2026, 22:01 (TU)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2017-07-27 00:00:00
open_canada_keywords	{"fr": ["modification proposée", "normes de bioéquivalence", "libération modifiée multiphasique", "produits médicamenteux", "présentations de drogue", "division C.08", "Règlement sur les aliments et drogues", "exigences comparatives en matière de biodisponibilité", "plasma multiphasique", "effet thérapeutique du produit"], "en": ["proposed modification", "bioequivalence standards", "multiphasic modified-release", "drug products", "drug submissions", "Division C.08", "Food and Drug Regulations", "comparativ e bioavailability requirements", "multiphasic plasma", "product’s therapeutic effect"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Avis : Modifications proposées aux normes en matière de bioéquivalence pour les produits pharmaceutiques à libération modifiée multiphasique
update_frequency	as_needed