Puzzle: Estimation of half life [Surveys]

posted by ElMaestro  – Denmark, 2013-02-12 20:42 (4062 d 15:44 ago) – Posting: # 10006
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Hi Helmut,

this happens occasionally with inhalation products and leaves everybody puzzled. If several subjects have such a profile one initial idea is to audit.
If nothing is found, and if SOPs are silent in relation to this situation, then I would say you can calculate AUCt but not kel or AUCinf for such subjects.
Hence I believe the subjects are not lost to evaluation of the primary endpoints Cmax and AUCt. You will of course get questions about the typical max. 20% extrapolation requirement which is impossible to answer in a meaningful manner. If you do business with some authority that requires AUCinf as primary then you have "an issue" and I have no solution which is universally useful.

Pass or fail!
ElMaestro

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