Camila
●    

2009-04-01 23:38
(5496 d 10:31 ago)

Posting: # 3449
Views: 4,022
 

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

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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]
 
drcampos
★    

Brazil,
2009-04-07 19:20
(5490 d 14:49 ago)

@ Camila
Posting: # 3497
Views: 3,162
 

 BCS based biowaiver and food effect

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Dear Camila,

These 2 articles may help you:

Fleisher D, Li C, Zhou Y, Pao LH, Karim A
Drug, meal and formulationnteractions influencing drug absorption after oral administration. Clinical implications
Clin Pharmacokinet. 1999 Mar;36(3):233-54. Review

Custodio JM, Wu CY, Benet LZ
Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption
Adv Drug Deliv Rev. 2008 Mar 17;60(6):717-33. Epub 2007 Nov 28.
Review.

best regards,

Daniel Rossi de Campos
Brazil
 
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