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Dear members,
Has anyone done any research on a single-dose, 3-way cross-over
Bioequivalence (BE) study with subcutaneous insulin as the active,
placebo as the control and incorporating a baseline evaluation, but not
using the clamp method
Since insulin is not a clinical drug but an endogenous substance, no
BA/BE guidelines are available.
We would like to request any member of this list who has done any kind
of Bioequivalence/pilot or any other study evaluating insulin levels
without using the clamp method to share your experience with us. More
precisely, is it viable and will regulatory authorities accept the
bioequivalence claim?
Thanks
Hanna-Liza Jooste
Biostatistician
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