Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies

Name: Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

To provide sponsors of new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations (Regulations) with respect to comparative bioavailability studies used in support of the safety and efficacy of a drug.

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

Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies (French, HTML) HTML
Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies (English, HTML) HTML

Related open data

Health Canada