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RegisterPuzzle: Estimation of half life [Surveys]
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.
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.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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 lifeElMaestro 2013-02-12 19:42
- Estimation of half life - LLPout rule d_labes 2013-02-12 19:46
- Puzzle: Estimation of half life jag009 2013-02-12 20:50
- Excluding increasing concentration(s) Helmut 2013-02-13 12:41
Ing. Helmut Schütz