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Registerfailed bioequivalence study [Study Assessment]
HELP
have carried out bioequivalence study on sustained release formulation and the results between the test and reference drug were not satisfied as the geometric mean ratio for main pK parameters was less than 80% and the confidence interval for the three pharmacokinetic parameters fall outside the lower limit but it is within limit for the upper confidence limit
0.8 [>] CI [<] 1.25 , can you give me your opinion about these results and is these two drugs is totaly different or there is a possibility of sucess for this study and how.
very thanks
Amr hussein
Edit: Category changed. [Helmut]
have carried out bioequivalence study on sustained release formulation and the results between the test and reference drug were not satisfied as the geometric mean ratio for main pK parameters was less than 80% and the confidence interval for the three pharmacokinetic parameters fall outside the lower limit but it is within limit for the upper confidence limit
0.8 [>] CI [<] 1.25 , can you give me your opinion about these results and is these two drugs is totaly different or there is a possibility of sucess for this study and how.
very thanks
Amr hussein
Edit: Category changed. [Helmut]
Complete thread:
- failed bioequivalence studyA-M-R 2009-05-24 13:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- failed bioequivalence study ElMaestro 2009-05-24 14:48
Ing. Helmut Schütz