Biowaiver based on biopharmaceutics classification system: Considerations and requirements
Biowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System (BCS) are required to satisfy regulators in the U...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2024-12-01
|
| Series: | Pharmaceutical Science Advances |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2773216923000181 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|