pre-dose concentrations above LLOQ: useful topics [Bioanalytics]

posted by mittyri – Russia, 2015-08-30 21:24 (3456 d 14:45 ago) – Posting: # 15364
Views: 4,971

Dear Mitesh,

I think you can find the answer in the following topics: here, here or here

In a nutshell:
EMA BE GL states:
Reanalysis of study samples should be predefined in the study protocol (and/or SOP) before the actual start of the analysis of the samples.

EMA bioanalytical method validation GL states that:
In case of reanalysis because of positive pre-dose samples or because of a pharmacokinetic reason, the reanalysed samples should be identified and the initial value, the reason for reanalysis, the values obtained in the reanalyses, the finally accepted value and a justification for the acceptance should be provided

Hope it helps

Kind regards,
Mittyri

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