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

Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products 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. 2023-12-24 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyproposed modificationbioequivalence standardsmultiphasic modified-releasedrug productsdrug submissionsDivision C.08Food and Drug Regulationscomparativ e bioavailability requirementsmultiphasic plasmaproduct’s therapeutic effect Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug ProductsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/multiphasic-modified-release.html Notice: Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug ProductsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/participation-public-consultations/medicaments/liberation-modifiee-multiphasique.html

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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