Guidance document : comparative pharmacokinetic studies for orally inhaled products.: H164-302/2020E-PDF
"Comparative pharmacokinetic studies should be conducted in accordance with generally accepted clinical practices. These practices are designed to ensure the protection of the rights, safety and well-being of subjects. Good Clinical Practices are referred to in Division 5 of the Regulations, and described in the International Council for Harmonisation (ICH) Guidance (Topic E6) on Good Clinical Practice. To ensure compliance with the Regulations, follow the recommendations included in this guidance respecting study design and the conduct of comparative pharmacokinetic studies involving subsequent-entry orally inhaled drug products (OIPs)"--Policy statement, page 5.
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| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : comparative pharmacokinetic studies for orally inhaled products. |
| Variant title | Comparative pharmacokinetic studies for orally inhaled products |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. Issued also in HTML format. "Effective date: 2020/12/21." Issued also in French under title: Ligne directrice : études pharmacocinétiques comparatives sur les produits administrés par inhalation orale. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (11 pages) |
| ISBN | 9780660364803 |
| Catalogue number |
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| Departmental catalogue number | 200255 |
| Subject terms | Pharmacokinetics. Oral medication -- Government policy -- Canada. |
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