Bioequivalence and Bioavailability Forum

Dear All,

Can any body throw some more light on this, as per FDA guidline, "
Data deletion due to vomiting:
• We recommend that data from subjects who experience emesis during the course of a BE Study for immediate-release products be deleted from statistical analysis if vomiting occurs at or before 2 times median Tmax. In the case of modified-release products, the data from Subjects who experience emesis any time during the labeled dosing interval can be deleted."

From where to take the median Tmax? Is it from the same study (i.e. after considering the subject who had emesis during the clinical phase PK and stat to be conducted and then based on the result his inclusion to be decided) or from the published literature? If it is from the same study we will have to continue the subject in the clinical phase which may be unethical if we are sure that this subject is definitely will fall in the said window (i.e. 2 times median Tmax) and if from the published literature then chances of getting different median Tmax value is also more.

Thanking you in advance.

Best regards,
Ratnakar