Log in
RegisterMaximum number of repeats in the BE study [Bioanalytics]
Hi!
To my knowledge there is no explicit acceptable %-number for re-analysed samples in BE studies stated in any country's guideline.
best regards
Hermann
P.S.: But you are right with 20% for ANVISA:
Resolution - RE nº 896 of 29 May 2003 states
2. Analytical stage
e) the analytical protocol shall contain the criteria for the re-analysis of the samples; no more than 20% of the samples may be re-analyzed;
...and also don't forget this one:
i) the analytical protocol shall contain the sample's data reintegration criteria;
There was an update (RE nº 397 of 12 Nov 2004), but has not been translated into English yet and is not available - even in Portuguese - at ANVISA's website.
To my knowledge there is no explicit acceptable %-number for re-analysed samples in BE studies stated in any country's guideline.
best regards
Hermann
P.S.: But you are right with 20% for ANVISA:
Resolution - RE nº 896 of 29 May 2003 states
2. Analytical stage
e) the analytical protocol shall contain the criteria for the re-analysis of the samples; no more than 20% of the samples may be re-analyzed;
...and also don't forget this one:
i) the analytical protocol shall contain the sample's data reintegration criteria;
There was an update (RE nº 397 of 12 Nov 2004), but has not been translated into English yet and is not available - even in Portuguese - at ANVISA's website.
Complete thread:
- Maximum number of repeats in the BE study SIVAPRASAD 2005-05-19 13:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Maximum number of repeats in the BE studyH_Rotter 2005-05-21 17:04
- Repeats in the BE study (ANVISA) Helmut 2007-09-02 12:29
- Maximum number of repeats in the BE studyH_Rotter 2005-05-21 17:04
Ing. Helmut Schütz