Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document

Name: Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

This information will help sponsors comply with the Food and Drug Regulations (Regulations), with respect to comparative studies, with emphasis on in vivo comparative pharmacokinetic studies, used in support of the safety and efficacy of subsequent-entry orally inhaled drug products (OIPs).

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2023-10-28

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document (French, HTML) HTML
Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document (English, HTML) HTML

Related open data

Health Canada