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Registerselegiline [Design Issues]
Hello drgunasakaran1
I always get a little sceptical when the intraCV seems a lot higher for AUC than for Cmax. I recommend my clients to audit the study whenever it happens, but I do acknowledge that it does happen now and then, though, especially if the study is very small.
Did you by an chance look at why? Look at monitor reports, do an audit, check chromatograms near the LLOQ?
❝ In one of our pilot study with Selegiline, we had an Intrasubject CV% of 54.3% for Cmax and 61.2% for AUC.
I always get a little sceptical when the intraCV seems a lot higher for AUC than for Cmax. I recommend my clients to audit the study whenever it happens, but I do acknowledge that it does happen now and then, though, especially if the study is very small.
Did you by an chance look at why? Look at monitor reports, do an audit, check chromatograms near the LLOQ?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- selegiline AB 2012-09-12 13:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- selegiline drgunasakaran1 2012-09-12 14:22
- selegiline AB 2012-09-12 16:24
- selegiline drgunasakaran1 2012-09-14 13:21
- selegilineElMaestro 2012-09-14 16:06
- selegiline jag009 2012-09-17 16:50
- selegiline AB 2012-09-12 16:24
- selegiline drgunasakaran1 2012-09-12 14:22
Ing. Helmut Schütz