Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products

Name: Notice: Policy on Bioequivalence Standards for Highly Variable 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 (that is [i.e.], new drug and abbreviated new drug submissions) of changes in Health Canada's comparative bioavailability requirements for drug products which exhibit large pharmacokinetic within-subject variation in extent of absorption, as measured by area under the concentration versus time curve (AUC).

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2021-06-01

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products (English, HTML) HTML
Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products (French, HTML) HTML

Related open data

Health Canada