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
| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Guidance for industry, preparation of the quality information for drug submissions in the CTD format : biotechnological/ biological (biotech) products. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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 |
| Description | 1 online resource (72 pages) |
| ISBN | 9780660273358 |
| Catalogue number |
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| Departmental catalogue number | Pub.: 180208 |