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Dear Colleagues,
In conducting BE study (for 2 iv inj. formulations) if
AUClast is ~90% of AUCinf but blood samples were
obtained for 3 half-life (t1/2~9, last sample=24 h),
is this adequate? Appreciate your input.
Rostam
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Yes, it should be sufficient since more than 80% of the AUCo-infinity
was covered by the blood-collection time-interval.
By the way it is unusual to perform BE studies on iv formulations? Did
I understand correctly those were iv drug-products?
radu
Radu D. Pop
Director Biopharmaceutics
Pharma Medica Research Inc.
966 Pantera Drive
Mississauga, Ontario
Canada, L4W 2S1
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Radu,
Thanks for your response, that is why I thought. Your
understanding is correct, it is not common but here
and there you may end up doing it.
Rostam
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