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RegisterJustification for the lack of ISR data [Bioanalytics]
Dear All
I expect that many of you will have come across regulators who apply current bioanalytical guidelines to studies which were completed prior to 2011, without ISR.
The PKWP Q&A document from 10 DEC 2012 suggests that scientific justification for the lack of ISR might include taking into consideration "the width of the 90% confidence interval and the ratio to possibly justify that a false positive outcome due to ISR problems has a low probability".
Any ideas as to exactly how this might be achieved?
KR
Andrew Leary
I expect that many of you will have come across regulators who apply current bioanalytical guidelines to studies which were completed prior to 2011, without ISR.
The PKWP Q&A document from 10 DEC 2012 suggests that scientific justification for the lack of ISR might include taking into consideration "the width of the 90% confidence interval and the ratio to possibly justify that a false positive outcome due to ISR problems has a low probability".
Any ideas as to exactly how this might be achieved?
KR
Andrew Leary
Complete thread:
- Justification for the lack of ISR dataDr Andrew Leary 2013-03-18 09:52
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Justification for the lack of ISR data ElMaestro 2013-03-18 10:13
- Justification for the lack of ISR data Dr Andrew Leary 2013-03-18 13:02
- Justification for the lack of ISR data ElMaestro 2013-03-18 10:13
Ing. Helmut Schütz