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Hi, all:
On the similar subject, recently, I was given the assignment to do
one single dose BE study and one multiple dose BE study (was told
that European submission requires multiple BE for a CR product).
During the course, we realize that why can't we just combine two?
But I don't really see this being the routine practice to combine
single and multiple BE in one study, so want to check whether I miss
anything. Internally, we do this combined study (single and
multiple), but it is not designed per bioequivalent purpose.
Could someone let me know if there is any strong reason that we
should do the two studies separately? What is your experience/
recommendation?
Additional info below.
Two treatments: A: 2X 5 mg
B: 10 mg
2 treatment, 2 period, crossover study. In each treatment, Dosing on
Day 1 (single dose portion) and then starting on Day 4, daily dosing
for 5 days (multiple dose portion) {predicted concentration at 72
hr post single dosing is BLQ}
PK sampling: 0-72 hr following the single dose, 0-56 hr following
the last dosing on Day 8
Washout: 6-16 days
Number of subjects: 52 to complete 44
The combined blood volume would be less 500 mL in 11 days.
There is no known induction/inhibition of metabolism.
Thank you so much for your time! Ying
Ying Ou
ALZA/J&J
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