BCS based biowaiver and food effect [Dissolution / BCS / IVIVC]

posted by Camila – 2009-04-01 23:38 (6285 d 07:09 ago) – Posting: # 3449
Views: 6,219

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]

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