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Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies

Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability Studies".

Bioavailability is an important attribute of formulations of drugs used for systemic effects. It is defined as the rate and extent of drug entry into systemic circulation.

Comparative bioavailability studies should be conducted in accordance with generally accepted clinical practices that are designed to ensure the protection of the rights, safety, and well-being of subjects and the good clinical practices described in the International Council for Harmonisation (ICH) Guidance (Topic E6) on Good Clinical Practice.

In order to ensure compliance with the Regulations, this guidance includes recommendations regarding study design and conduct, validation of bioanalytical methodology, and statistical analysis of data.

This guidance is intended to be applied to all comparative bioavailability studies which provide pivotal evidence of the safety and efficacy of a product, with the exception of subsequent-entry biologic products.

Bioequivalence implies that the test product can be expected to have the same therapeutic effects and safety profile as the reference product when administered to patients under the conditions specified in the labelling.

The main objective of this guidance is to provide sponsors of new drug submissions with the information necessary to comply with the Food and Drug Regulations with respect to comparative bioavailability studies used in support of the safety and efficacy of a drug.

Click this LINK to know more about the requirements for implementation.


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