bioanalytical validation runs [Bioanalytics]

posted by xtianbadillo – Mexico, 2018-01-18 16:31 (1898 d 12:12 ago) – Posting: # 18213
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Hello Samar:

❝ 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...)

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