Language selection

Government of Canada / Gouvernement du Canada

Search

Guidance document : conduct and analysis of comparative bioavailability studies.: H13-9/6-2018E-PDF

"Policy objectives: To provide sponsors of new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations (Regulations) with respect to comparative bioavailability studies used in support of the safety and efficacy of a drug"--Introd., p. 9.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.852787&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitleGuidance document : conduct and analysis of comparative bioavailability studies.
Variant title
  • Conduct and analysis of comparative bioavailability studies
  • Conduct & analysis of comparative bioavailability studies
Publication typeMonograph
Language[English]
Other language editions[French]
Later editionGuidance document :
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Ligne directrice : conduite et analyse des études de biodisponibilité comparatives.
  • Cover title.
  • "Date adopted: 2012/02/08. Revised date: 2018/06/08. Effective date: 2018/09/01 (for submissions filed on or September 1, 2018)."
  • "Publication date: June 2018."
  • Issued also in HTML format.
Publishing information
  • Ottawa : Health Canada, 2018.
Description35 p. : charts.
ISBN9780660255125
Catalogue number
  • H13-9/6-2018E-PDF
Departmental catalogue number170507
Subject terms
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.

Page details

Report a problem or mistake on this page
Date modified: