Bioequivalence and Bioavailability Forum

Dear Smitha
To my opinion there is no justification to exclude the subject with first point Cmax from PK and Statistical analysis. First of all you have to check if this occurred under Test because then you maybe have to face a formulation problem (dose dumping -> serious risk to public health). Next you should check if the first concentration measured is within the range of Cmax of the study. If not and above the range, than you have a problem. Otherwise evaluate the full data set and if the study passes perform a sensitivity analysis by replacing the first concentration measured by the highest Cmax measured in the study. If the study still passes than try to find the highest Cmax value for this subject that still allows to conclude bioequivalence and discuss why the first concentration measured is supposed to be the Cmax of the subject. Do not exclude the subject from PK and Statistical analysis.
I hope this helps.
Kind regards
Dan