Posting: # 36
With reference to ANDA submission for US FDA, If the prescribing information says that the drug has to be taken under fed condition then whether it is necessary to conduct both fasted and fed studies? Can we only submit the fed study for immediate release formulation?
Posting: # 38
'…, we recommend that where the focus is on release of the drug substance from the drug product into the systemic circulation, a single-dose, fasting study be performed.'
'In addition to a BE study under fasting conditions, we recommend a BE study under fed conditions for all orally administered immediate-release drug products, with the following exceptions:
Anyhow, if the food effect documented in the reference's SmPC is safety-related (i.e., AEs due to GI-disturbances), you may start an argument.
Remark: in such a case European Guidelines call only for a fed study.
Edit: Links corrected for FDA’s new site. [Helmut]
The quality of responses received is directly proportional to the quality of the question asked. ☼
Posting: # 39
The reasoning behind is that although you write something in the SPC, there is no guarantee, that patients act accordingly, i.e. swallow your drug together with food. Maybe they 'know' that any drug acts 'faster'/'better' if adminstered on an empty stomach, or they don't even read the SPC.
» Anyhow, if the food effect documented in the reference's SmPC is
» safety-related (i.e., AEs due to GI-disturbances), you may start an
Yes, but: see above
» Remark: in such a case European Guidelines call only for a fed
Again yes, but: I've heard of an application where the Dutch regulators wanted to see a fasting study - after the submitted fed study (which showed BE).
Regulators have all post approval data of the inovator's product on file; maybe that's the reason.