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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.893026&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance document : comparative pharmacokinetic studies for orally inhaled products. |
| Variante du titre | Comparative pharmacokinetic studies for orally inhaled products |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| 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. |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (11 pages) |
| ISBN | 9780660364803 |
| Numéro de catalogue |
|
| Numéro de catalogue du ministère | 200255 |
| Descripteurs | Pharmacokinetics. Oral medication -- Government policy -- Canada. |
Demander des formats alternatifs
Pour demander une publication dans un format alternatif, remplissez le formulaire électronique des publications du gouvernement du Canada. Utilisez le champ du formulaire «question ou commentaire» pour spécifier la publication demandée.- Date de modification :