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Hello everyone,
I am designing a study for an aqueous based IV formulation for FDA
submission. I was wondering if there is a requirement or any BE
guidelines available for such parenterals.
Thanks in advance,
Sreeneeranj Kasichayanula
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The following message was posted to: PharmPK
No need for BE, if the formulation prepared as solution to be given
by IV route.
With kind respect & regard.
Professor Khalil I M Al-Khamis, Ph.D
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