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Quality (chemistry and manufacturing) guidance : new drug submissions and abbreviated new drug submissions.H164-266/2024E-PDF

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.945784&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleQuality (chemistry and manufacturing) guidance : new drug submissions and abbreviated new drug submissions.
Publication typeMonograph
Language[English]
Other language editions[French]
Earlier editionGuidance document :
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice sur la qualité (chimie et fabrication) : présentations de drogue nouvelle et présentations abrégées de drogue nouvelle.
  • "Date adopted 2017-10-30. Revised date 2024-12-18. Effective date 2024-12-18."
  • "Pub.: 240665."
  • Includes bibliographical references.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, December 2024.
  • ©2024
Description1 online resource (v, 67 pages)
ISBN9780660747330
Catalogue number
  • H164-266/2024E-PDF
Subject terms
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