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RegisterPredose Conc [Bioanalytics]
Hai,
If a predose (without IS) shows a very high concentaration, as per the bioanalysit it is due to back calculation of analyte area, the analyte area is less than 20% compared to the Standard A. the IS area also very less compared to normal IS area. This is observed with few number of subjects Pk data.
Is this data acceptable or have to perform reanalysis?
Analysts states that this is not a peak and observed because of the noise
Kindly provide your views
Thanks in advance
Alhas
If a predose (without IS) shows a very high concentaration, as per the bioanalysit it is due to back calculation of analyte area, the analyte area is less than 20% compared to the Standard A. the IS area also very less compared to normal IS area. This is observed with few number of subjects Pk data.
Is this data acceptable or have to perform reanalysis?
Analysts states that this is not a peak and observed because of the noise
Kindly provide your views
Thanks in advance
Alhas
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Alhas
Alhas
Complete thread:
- Predose ConcBEAZ 2008-11-12 06:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Predose Conc kaushal09 2008-11-12 11:31
- Predose Conc Ohlbe 2008-11-12 12:00
- Predose Conc Geokad 2008-11-12 16:51
- Predose Conc srithan 2008-12-06 11:49
Ing. Helmut Schütz