Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products (English, HTML)

Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products: English HTML file. From Health Canada, updated Dec 2023. View metadata, licence and the direct download on CanQuery.

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Publisher-reported update

2023-12-24

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (i.e., new drug and abbreviated new drug submissions), of proposed modifications to Health Canada’s comparative bioavailability requirements when multiphasic plasma concentration profiles have been demonstrated to be integral to the product’s therapeutic effect.

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