Bioequivalence and Bioavailability Forum

Hi Pravin,

FDA states:

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 T_max. In the case of modified-release products, the data from subjects who expe­ri­ence emesis any time during the labeled dosing interval can be deleted.

In the case of a DR product where t_max ≥ τ the absorption mainly is dependent on the (intrinsically variable) gastric emptying. I would strongly suggest to exclude subjects who vomited within 24 hours.