Notice: Clarification of bioanalytical method validation procedures

Notice: Clarification of bioanalytical method validation procedures The purpose of this notice is to clarify Health Canada’s interpretation and expectations for all matrix-based stability experiments [that is (i.e.) Long term, Freeze-thaw and Bench top] conducted during bioanalytical method validation. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetynoticeclarification of bioanalytical methodbioanalytical method validationinterpretation and expectationsmatrix-basedstability experiments Notice: Clarification of bioanalytical method validation proceduresHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-clarification-bioanalytical-method-validation-procedures.html Notice: Clarification of bioanalytical method validation proceduresHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-clarification-procedures-validation-methodes-bioanalytiques.html

The purpose of this notice is to clarify Health Canada’s interpretation and expectations for all matrix-based stability experiments [that is (i.e.) Long term, Freeze-thaw and Bench top] conducted during bioanalytical method validation.

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