Method not sensitive enough [Study As­sess­ment]

posted by Aymanmy – Jordan, 2019-12-18 17:58  – Posting: # 21001
Views: 1,063

Hi Helmut and colleagues
thanks for your replies and interactions,
my concern is the study is already submitted by the sponsor to the H.A, and the study results are known, also the samples are out of studied long term stability, can we just exclude the results of the affected subjects from the statistics?
and plz to confirm that every individual subject should fulfil the less than 5% of Cmax criteria for the future?

thanks again very much for your inteaction, its highly appreciated.

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