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Guidance document : quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs).: H164-266/2018E-PDF

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.867966&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
  • Canada. Health Products and Food Branch.
TitleGuidance document : quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs).
Variant title
  • Quality (chemistry and manufacturing) guidance : new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs)
Publication typeMonograph
Language[English]
Other language editions[French]
Later editionQuality (chemistry and manufacturing) guidance :
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice : qualité (chimie et fabrication) : présentations de drogue nouvelle (PDN) et présentations abrégées de drogue nouvelle (PADN).
  • Cover title.
  • "Health Products and Food Branch."
  • Includes addendum (questions and answers).
  • Issued also in HTML format.
Publishing information
  • [Ottawa] : Health Canada = Santé Canada, [2017]
  • ©2017.
Description1 online resource (vi, 85 pages)
Catalogue number
  • H164-266/2018E-PDF
Subject terms
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