Description
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).
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document | HTML | Open resource | |
| Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document | HTML | Open resource |