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

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

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Formats: HTML
File languages: English, French

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Government of Canada Open Data
Open Government Licence – Canada

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Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects (English, HTML) HTML
Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects (French, HTML) HTML

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Health Canada