Camila
●    

2009-04-01 23:38
(6288 d 17:57 ago)

Posting: # 3449
Views: 6,229
 

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

Post reply
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
(6282 d 22:15 ago)

@ Camila
Posting: # 3497
Views: 4,909
 

 BCS based biowaiver and food effect

Post reply
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
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
170 visitors (0 registered, 170 guests [including 40 identified bots]).
Forum time: 17:35 CEST (Europe/Vienna)

I have finally come to the konklusion
that a good reliable set ov bowels
iz worth more to a man
than enny quantity of brains.    Josh Billings

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5