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

Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies: English HTML file. From Health Canada, updated Jun 2021. View metadata, licence and the direct download on CanQuery.

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HTML

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Publisher-reported update

2021-06-01

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.

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