Bioequivalence and Bioavailability Forum

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

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Edit: Category changed. [Helmut]