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