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The following message was posted to: PharmPK
I am working on BE study proposed as a part of ANDA
submission. I request you all to give me some insight
about the study from the regulatory perspective:
1. Is it necessary to do a fasting study for the
product to be administered only after the food?
2. If yes, what would be the criteria in case of the
highly variable drug that is passed in AUC but not in
Cmax due to its high variation in nature as per the
innovator's Product Information available as FOI of
Thanks in advance.
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