Puzzle: Estimation of half life [Surveys]

posted by jag009  – NJ, 2013-02-12 21:50 (4062 d 13:59 ago) – Posting: # 10008
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Hi Helmut,

The CRO that I outsourced before would consider the t1/2 to be "N.C" or Not calculated if the last pt (or 2 pts) showed an increase in concentration. I ran like 200 studies with them and about 100–150 studies were for FDA ANDA submission. The agency never came back with questions. Granted that this issue occurred in 2–5 subjects (with n=24+).

John

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