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Please let me know do we get a waiver from conducting In-vivo
bioequivalence study for a delayed release product to act locally for
If yes as per the General Considerations of US FDA guidelines then
Please let me know do we need to conduct the Study with an objective
of determinig the safety of the product for ANDA submission
Eagerly waiting for the replies....
Shaikh Feroz Ibrahim
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The following message was posted to: PharmPK
Dear Mr. Ibrahim,
Sorry for a late response.
First, regarding ANDA for locally acting oral drugs, FDA does not give
clear cut information whether we can go for an Biowaiver, since in their
Guidance for Industry, it is mentioned that BE to be proved with
clinical efficacy and safety studies (Ref Sec E). On the contrary, there
are few ANDA submissions with In-vivo BE studies for 5-ASA derivatives
such as Olsalazine and balsalazide, which are again locally acting
drugs, are being tried by certain generic manufacturers. It is better to
get it cleared from FDA, before proceeding further.
Second, you have mentioned Pantoprazole as a locally active drug, which
is not so. Even though it acts in the Parietal cells of the GIT, it can
get there only through blood. So if you are planning for a BE study with
Pantoprazole, please do a full fasting and fed bio studies (also an
applesauce study, if needed).
Please correct me if I am wrong.
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