Bioequivalence and Bioavailability Forum

Dear ssk,

The USFDA asks for both the fed and the fasting study to be carried out for all the drugs irrespective of the nature of the drug.
the european union however does not ask to conduct the BA in fed conditions in case the food does not have any effect on the BA of the drug as per literature.
hence it is dependent on the country to which you submit.

kamakshi

❝ Dear all,

❝ Why is both fed and fasting studies done in some studies? Is

❝ there any criteria to decide which type of study to be conducted?

❝ Thaking you,

❝ ssk

SSK, Fed BA studies, as told by kamakshi, are carried out for New Drug Products to asess the effects food on rate and extent of absorption of drug product. Fed BE studies are done for ANDA product to prove the bio-equivalence of generic product with the drug product listed in RLD. It is easily understood that drug product taken shortly after the meal will have grater food effect on it.

In case of new drug products there is no exception to fed and fast studies. However for ANDA product exception of fast studies will be based on following conditions.

1) If drug product and RLD show similar dissolution profiles and contain BCS class-1 drug substance.

2) If the label for RLD states that the drug should be taken only on empty stomach

3) if RLD does not make any statement regarding the effect of food on the rate and absorption of drug product.