Bioequivalence and Bioavailability Forum

❝ BE should be determined based on the overall treatment effect in the whole study population. The statistical model should take into account the multi-group nature of the BE study, e.g., by using a model including terms for group, sequence, sequence × group, subject within sequence × group, period within group and formulation. The group × treatment interaction term should not be included in the model. However, applicants should evaluate potential for heterogeneity of treatment effect across groups and discuss its potential impact on the study data, e.g., by investigation of group × treatment interaction in a supportive analysis and calculation of descriptive statistics by group.

• do you know the reason to include period within group and formulation? As far as I remember, Model I and Model II included Period(Group) factor only.
  
• What kind of descriptive statistics is expected? Everything above BE section stratified by group? What are the consequences of this evaluation of heterogeneity? Is it possible that assessor will be unhappy with the statistics of some group comparing to others? Since no tests are suggested (eyeball desc stat by group comparison?), any evidence provided post hoc are weak arguments