BCS based biowaiver and food effect [Dissolution / BCS / IVIVC]
Dear all,
Is it possible to biowaive a class I or III drug if its absorption is affected by food and the SPC recommends the administration with food? In other words, is the food effect a drawback to grant a biowaiver?
Regards,
Camila
Edit: Category changed. [Helmut]
Is it possible to biowaive a class I or III drug if its absorption is affected by food and the SPC recommends the administration with food? In other words, is the food effect a drawback to grant a biowaiver?
Regards,
Camila
Edit: Category changed. [Helmut]
Complete thread:
- BCS based biowaiver and food effectCamila 2009-04-01 21:38
- BCS based biowaiver and food effect drcampos 2009-04-07 17:20