Bioequivalence and Bioavailability Forum

❝ If any subject vomit between the day 1-2 and 1-4, what will be the withdrawal criteria? If steady state achive in three days and emesis occur on day one or day two should we continue the subjects.

• IR:  ≤2× median t_max of the reference.
  
• MR: anytime within the labeled dosing interval.

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. For modified release products, we recommend deleting data from the analysis if a subject vomits during a period of time less than or equal to the dosing interval stated in the labeling of the product.

Examples of reasons to exclude the results from a subject in a particular period are events such as vomiting […] which could render the plasma concentration-time profile unreliable.
The permitted reasons for exclusion must be pre-specified in the protocol. If one of these events occurs it should be noted in the CRF as the study is being conducted. Exclusion of subjects based on these pre-spe­ci­fied criteria should be clearly described and listed in the study report.