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Registerunexpected behavior for test product [Study Assessment]
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
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
Complete thread:
- Subject non compliance Loky do 2020-07-15 12:57 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject non compliance (or product failure?) Helmut 2020-07-16 14:30
- Subject non compliance (or product failure?) Loky do 2020-07-16 22:29
- Bad science (statistics is taboo) Helmut 2020-07-17 01:01
- unexpected behavior for test productLoky do 2020-07-22 11:29
- Subject-by-Formulation interaction? Helmut 2020-07-22 12:03
- Subject-by-Formulation interaction? Loky do 2020-07-26 11:30
- Subject-by-Formulation interaction? Helmut 2020-07-22 12:03
- unexpected behavior for test productLoky do 2020-07-22 11:29
- Bad science (statistics is taboo) Helmut 2020-07-17 01:01
- Subject non compliance (or product failure?) Loky do 2020-07-16 22:29
- Subject non compliance (or product failure?) Helmut 2020-07-16 14:30
Ing. Helmut Schütz