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.
Permanent link to this Catalogue record:
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| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Guidance document : comparative bioavailability standards : formulations used for system effects. |
| Variant title | Comparative bioavailability standards : formulations used for system effects |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| 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). |
| Publishing information | Ottawa : Health Canada, 2018. |
| Description | 16 p. |
| ISBN | 9780660255149 |
| Catalogue number |
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| Departmental catalogue number | 170501 |
| Subject terms | Drug approval Drugs--Bioavailability Drugs--Therapeutic equivalency Standards |