unexpected behavior for test product [Study As­sess­ment]

posted by Loky do – Egypt, 2020-07-22 09:29 (298 d 12:03 ago) – Posting: # 21774
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Thanks for your reply :-):-)

Now another case for a non highly variable drug, a bioequivalence study performed on 27 subjects, where only 2 subjects had an odd behavior for test product (almost double the concentration of the reference product also double concentration of the rest of test product's subjects) and accordingly the study failed :-| and by excluding the probability of double dosing the 2 subjects by mistake (accountabilities are correct), and the results of incurred sample reanalysis for both are satisfactory :confused:
Is it applicable to consider these subjects as outliers, is there any way to conclude this? or could we re-dose them again to be confirmed? or simply the product fails :-|?

thanks :-)

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