Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects

Name: Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2021-06-01. On CanQuery you can follow the original downloads. Files are available in English and French.

To ensure that sponsors of new drug submissions have 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 with respect to comparative bioavailability and comparative pharmacodynamic 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 - Comparative Bioavailability Standards: Formulations Used for Systemic Effects (English, HTML) HTML · Download HTML
Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects (French, HTML) HTML · Download HTML

Related open data

Health Canada