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RegisterStatistical analysis of Cmax values < LOQ [General Statistics]
Dear all
I totally agree with ElMaestro
According to guideline CPMP/QWP/EWP/1401/98 Rev. 1 "The lower limit of quantitation should be 1/20 of Cmax or lower". If you can not detect any plasma levels in 40% of your subjects the you will have on the one hand a drug with a high inter-subject variability and on the other hand an analytical method which is not sensitive enough to cover the whole range of plasma concentrations. This is the most critical point and you will not convince any assessor with a statistical evaluation when your analytical method is not suitable except you can show that you had 40% of non-compliers.
Kind regards
Dan
I totally agree with ElMaestro
❝ It is not clear what the purpose of the trial is but I am willing to bet a monthly salary on the fact that the study report when reviewed by an assessor will not do much for you, whatever you do.
According to guideline CPMP/QWP/EWP/1401/98 Rev. 1 "The lower limit of quantitation should be 1/20 of Cmax or lower". If you can not detect any plasma levels in 40% of your subjects the you will have on the one hand a drug with a high inter-subject variability and on the other hand an analytical method which is not sensitive enough to cover the whole range of plasma concentrations. This is the most critical point and you will not convince any assessor with a statistical evaluation when your analytical method is not suitable except you can show that you had 40% of non-compliers.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Statistical analysis of Cmax values < LOQ martin 2010-09-29 19:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Statistical analysis of Cmax values < LOQ Helmut 2010-09-29 19:49
- Statistical analysis of Cmax values < LOQ ElMaestro 2010-09-29 23:20
- Statistical analysis of Cmax values < LOQ Ohlbe 2010-09-30 09:14
- Statistical analysis of Cmax values < LOQ Helmut 2010-09-30 13:39
- TK study martin 2010-09-30 21:53
- Censored or truncated d_labes 2010-10-01 11:49
- TK study martin 2010-09-30 21:53
- Statistical analysis of Cmax values < LOQ ElMaestro 2010-10-01 17:53
- Statistical analysis of Cmax values < LOQ Helmut 2010-09-30 13:39
- Statistical analysis of Cmax values < LOQDr_Dan 2010-09-30 09:52
- Statistical analysis of Cmax values < LOQ Ohlbe 2010-09-30 09:14
- Statistical analysis of Cmax values < LOQ ElMaestro 2010-10-01 18:13
Ing. Helmut Schütz