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RegisterDifference in values between reanalysed and ISR samples [Bioanalytics]
Dear Cakhatri,
According to EMEA Guideline on Bioanalytical Method Validation (2011), the concentration obtained for the initial analysis and reanalysis should be within 20% of their mean for at least 67% of the repeats. Large differences between results may indicate analytical issues and should be investigated.
If I interpret the guideline correctly, as long as you have more than 67% of the repeats within 20% of their means, you are safe.
What do you mean when you mentioned "ISR passed with more than 95% acceptance criteria" ?
I have no experience dealing with FDA on ISR. Any guideline by FDA on this matter ??
Regards,
Ken
According to EMEA Guideline on Bioanalytical Method Validation (2011), the concentration obtained for the initial analysis and reanalysis should be within 20% of their mean for at least 67% of the repeats. Large differences between results may indicate analytical issues and should be investigated.
If I interpret the guideline correctly, as long as you have more than 67% of the repeats within 20% of their means, you are safe.
What do you mean when you mentioned "ISR passed with more than 95% acceptance criteria" ?
I have no experience dealing with FDA on ISR. Any guideline by FDA on this matter ??
Regards,
Ken
Complete thread:
- Difference in values between reanalysed and ISR samples cakhatri 2013-03-10 09:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Difference in values between reanalysed and ISR samples Ohlbe 2013-03-11 18:58
- Difference in values between reanalysed and ISR samples cakhatri 2013-03-12 05:24
- Difference in values between reanalysed and ISR samplesKen Peh 2013-03-16 14:40
- Difference in values between reanalysed and ISR samples Ohlbe 2013-03-11 18:58
Ing. Helmut Schütz