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Guidance for industry, preparation of the quality information for drug submissions in the CTD format : biotechnological/ biological (biotech) products.: H164-242/2018E-PDF

"This document is intended to provide additional guidance to industry, for the preparation of the quality information for Drug Submissions, structured using the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format"--Introduction, page 7.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.859401&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitleGuidance for industry, preparation of the quality information for drug submissions in the CTD format : biotechnological/ biological (biotech) products.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice à l'intention de l'industrie, préparation des données sur la qualité pour les présentations de drogues dans le format CTD : produits biologiques ou issus de la biotechnologie.
  • Cover title.
  • "Publication date: August 2018."
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2018.
  • ©2018
Description1 online resource (72 pages)
ISBN9780660273358
Catalogue number
  • H164-242/2018E-PDF
Departmental catalogue numberPub.: 180208
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