Generally, I would say yes, unless there is a scientific or logistical reason not to do it. For example, if it is not possible to administer the product IV. Or, animal studies indicate that it is nearly 100% bioavailability and studies in humans are consistent with that.
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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 10-Sep-2018 10:54
From: Anonymous Member
Subject: Absolute Bioavailability Study
This message was posted by a user wishing to remain anonymous
Is it a requirement to conduct an absolute bioavailability study for NDA approval?
Thank you!