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

Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects: French HTML file. From Health Canada, updated Jun 2021. View metadata, licence and the direct download on CanQuery.

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Publisher-reported update

2021-06-01

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.

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