Bioequivalence and Bioavailability Forum

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 
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