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RegisterBioequivalence decision affected by ISR? [Bioanalytics]
Dear all
In order to reduce the variability in outcome in bioequivalence studies all samples of one subject together are analysed in one analytical run (including calibration standards, QC samples, and study samples). The samples are handled at the same time, i.e. subsequently processed without interruption in time and by the same analyst with the same reagents under homogeneous conditions. The QC samples are divided over the run in such a way that the accuracy and precision of the whole run is ensured. So, if anything happens during bioanalysis (instrument issues, scientist performance of method, metabolite interferences, back conversion of metabolites, poor ruggedness, internal standard response, matrix effects) which could have been detected by ISR this would affect the samples derived from test treatment in the same way as the samples derived from reference treatment (at least in studies with a cross-over design), right? In consequence, even if the absolute concentration determined in the samples is not correct the relative difference of test and reference i.e. the ratio for AUC and Cmax should be the same. Therefore I argue that the bioequivalence decision based on a validated bioanalytical method will not be affected by the (missing) results of ISR.
Do you agree with these considerations?
I am looking forward to your valuable thoughts.
Kind regards
Dan
In order to reduce the variability in outcome in bioequivalence studies all samples of one subject together are analysed in one analytical run (including calibration standards, QC samples, and study samples). The samples are handled at the same time, i.e. subsequently processed without interruption in time and by the same analyst with the same reagents under homogeneous conditions. The QC samples are divided over the run in such a way that the accuracy and precision of the whole run is ensured. So, if anything happens during bioanalysis (instrument issues, scientist performance of method, metabolite interferences, back conversion of metabolites, poor ruggedness, internal standard response, matrix effects) which could have been detected by ISR this would affect the samples derived from test treatment in the same way as the samples derived from reference treatment (at least in studies with a cross-over design), right? In consequence, even if the absolute concentration determined in the samples is not correct the relative difference of test and reference i.e. the ratio for AUC and Cmax should be the same. Therefore I argue that the bioequivalence decision based on a validated bioanalytical method will not be affected by the (missing) results of ISR.
Do you agree with these considerations?
I am looking forward to your valuable thoughts.
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:
- Bioequivalence decision affected by ISR?Dr_Dan 2012-12-21 09:52
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence decision affected by ISR? Ohlbe 2012-12-21 10:30
- Bioequivalence decision affected by ISR? Dr_Dan 2012-12-21 15:31
- Bioequivalence decision affected by ISR? Ohlbe 2012-12-21 19:12
- Lousy studies? Helmut 2012-12-21 20:19
- Bioequivalence decision affected by ISR? Ohlbe 2012-12-21 19:12
- Bioequivalence decision affected by ISR? Dr_Dan 2012-12-21 15:31
- Tricky question Helmut 2012-12-21 15:23
- Add'l requirements ElMaestro 2012-12-23 05:10
- Bioequivalence decision affected by ISR? Ohlbe 2012-12-21 10:30
Ing. Helmut Schütz