Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products

Name: Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2023-12-24. On CanQuery you can follow the original downloads. Files are available in English and French.

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-12-24

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Formats: HTML
File languages: English, French

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