Updated TPD BE guidances [BE/BA News]

posted by BRB  – Canada, 2018-06-18 20:53 (946 d 12:32 ago) – Posting: # 18915
Views: 2,995

Hello everyone,

Health Canada recently posted their updated BE guidances:

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.pdf

https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/bio/comparative-bioavailability-standards-formulations-used-systemic-effects.pdf

The effective date is July 1 (Canada day!)

Regards,
BRB


Edit: Category changed; see also this post #1[Helmut]

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