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Registerbioanalytical validation runs [Bioanalytics]
Hello Samar:
QCs must be include within study samples but not in each validation run: "An analytical run consists of the blank sample (processed matrix sample without analyte and without IS) and a zero sample (processed matrix with IS), calibration standards at a minimum of 6 concentration levels, at least 3 levels of QC samples (low, medium and high) in duplicate (or at least 5% of the number of study samples, whichever is higher), and study samples to be analysed" EMA Guideline
As Helmut and ElMaestro have said there are validation paramaters that do not requires QCs (selectivity, matrix effects...)
❝ According to EMA and FDA guidlines, should we include quality control samples in each validation run (matrix effect, Reccovery, stability,,, )?
QCs must be include within study samples but not in each validation run: "An analytical run consists of the blank sample (processed matrix sample without analyte and without IS) and a zero sample (processed matrix with IS), calibration standards at a minimum of 6 concentration levels, at least 3 levels of QC samples (low, medium and high) in duplicate (or at least 5% of the number of study samples, whichever is higher), and study samples to be analysed" EMA Guideline
As Helmut and ElMaestro have said there are validation paramaters that do not requires QCs (selectivity, matrix effects...)
Complete thread:
- bioanalytical validation runs samar sameh 2017-12-21 08:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- QCs in all runs Helmut 2017-12-21 14:53
- bioanalytical validation runs ElMaestro 2017-12-21 17:30
- bioanalytical validation runsxtianbadillo 2018-01-18 15:31
Ing. Helmut Schütz