How to evaluate Stock solution stability according to EMA guideline [Bioanalytics]

posted by EKY – Thailand, 2018-05-23 03:59  – Posting: # 18800
Views: 1,675

(edited by Ohlbe on 2018-05-23 11:03)

From the "Guideline on bioanalytical method validation" (EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2**, 21 July 2011) in Topic "4.1.9 Stability" mentioned about the stability of stock and working solutions that ' It is not need to study the stability at each concentration level of working solutions and a bracketing approach can be used'.

Which concentration should be use for bracket study in this experiment? It is need to be at ULOQ and LLOQ concentration, or not?

Can use high and low QC concentration (HQC, LQC) for this experiment as same as the other stability evaluations (in matrix)?


Edit: category changed [Ohlbe]

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