Bioequivalence and Bioavailability Forum

Dear Dr. Pravin!

❝ i want to know that what diferent guidelines say about the analysis of the withdrawl subject irrespective of the reason.

According to the European Guideline (3.8 Reporting of results):

'All results should be clearly presented and should include data from subjects who eventually dropped-out. Drop-out and withdrawal of subjects should be fully documented and accounted for.'

In other words, you should analyze all available data and present them in the report. Since a comparison of BE is only possible for complete data, the only possible situation I can imagine where you may include the subject is withdrawal after the last sampling time point of the last treatment period.

For other regulations please consult the Guidance Page.

❝ if guideline says that you can not analyse the withdrawal subject then, can principal investigator over ruled the guideline about the analysis of the subject with proper justification?

Why not? But generally you should have foreseen such a situation in the protocol...
I would advise you to lay down at least a 'Note to File' - or even better an amendment to the statistical analysis plan - before starting the actual BE assessment. Otherwise regulators may get the impression you are on the slippery track of 'data mining'...
Only one data set can be primary ('confirmatory analysis' supporting your decision of BE), the other one is only supportive ('exploratory analysis'). You must include both analyses in you report.