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

Name: Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-12-24

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products (French, HTML) HTML
Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products (English, HTML) HTML

Related open data

Health Canada