Guidance document : comparative bioavailability standards : formulations used for system effects. : H13-9/7-2018E-PDF
"Policy objectives: To ensure that sponsors of new drug submissions have 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 with respect to comparative bioavailability and comparative pharmacodynamic studies used in support of the safety and efficacy of a drug"--Introd., p. 9.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.852795&sl=1
| Ministère/Organisme | Canada. Health Canada. |
|---|---|
| Titre | Guidance document : comparative bioavailability standards : formulations used for system effects. |
| Variante du titre | Comparative bioavailability standards : formulations used for system effects |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Issued also in French under title: Ligne directrice : normes en matière d’études de biodisponibilité comparatives : formes pharmaceutiques de médicaments à effets systémiques. Cover title. "Date adopted: 2012/12/08. Revised date: 2018/06/08. Effective date: 2018/07/01 (for submissions filed on or September 1, 2018)." "Publication date: June 2018." Issued also in HTML format. Includes bibliographical references (p. 14). |
| Information sur la publication | Ottawa : Health Canada, 2018. |
| Description | 16 p. |
| ISBN | 9780660255149 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 170501 |
| Descripteurs | Drug approval Drugs--Bioavailability Drugs--Therapeutic equivalency Standards |