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
| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Guidance document : conduct and analysis of comparative bioavailability studies. |
| Variant title | Conduct and analysis of comparative bioavailability studies Conduct & analysis of comparative bioavailability studies |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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. |
| Description | 35 p. : charts. |
| ISBN | 9780660255125 |
| Catalogue number |
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| Departmental catalogue number | 170507 |
| Subject terms | Drug approval Drugs--Bioavailability Handbooks |