Bioequivalence and Bioavailability Forum

Hi all,

Apparently not...

Question. If a study requires partial AUC at early phase of the plasma concentration-time curve, is it acceptable to implement in the protocol "Subject will be removed from the study if more than x blood draws cannot be collected within x min of schedule time during post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4 hours?"

Given the fact that the variability of PAUC can be high, can the above be implemented at all? I know it probably doesn't happen but...
Obvious with the above example, the subject will be dropped out if he/she misses the 4 hr sample since PAUC0-4 requires 4 hour timepoint.

My answer to my questio? "As long as you state it in the protocol" Why I asked? Tada, some CRO managed to screw up some early timepoint collection by as much as 35mins!

Thanks

John

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Edit: Category changed. [Helmut]