Camila ● 2009-04-01 23:38 (5475 d 04:06 ago) Posting: # 3449 Views: 3,944 |
|
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 (5469 d 08:24 ago) @ Camila Posting: # 3497 Views: 3,098 |
|
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 |