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RegisterPuzzle: Estimation of half life [Surveys]
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
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
Complete thread:
- Puzzle: Estimation of half life Helmut 2013-02-12 19:12 [Surveys]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Puzzle: Estimation of half life ElMaestro 2013-02-12 19:42
- Estimation of half life - LLPout rule d_labes 2013-02-12 19:46
- Puzzle: Estimation of half lifejag009 2013-02-12 20:50
- Excluding increasing concentration(s) Helmut 2013-02-13 12:41
Ing. Helmut Schütz