Bioequivalence and Bioavailability Forum

❝ If some subject leave some food in the post dose lunch of 4 hrs, then we need to inform it to Pharmakokinetic department or not?

❝ And what is the criteria for that to continue subject or not ?

• Mention it in the report as a protocol deviation and discuss a potential influence on the outcome of the study.
  
• If the study is ongoing, consider serving a reduced amount of food in subsequent period(s) to this particular subject. Any potential food effect should mean out in a cross-over.
  
• Know your formulation. In a fasted BE study of an IR formulation or an multiparticulate MR formulation it shouldn’t be a big deal. For a monolithic MR formulation with a documented food effect it might matter. Amend the protocol (or at least set up a note to file): Run an outlier test and exclude the subject if significant - supported by statistics and justified by the deviation from the protocol.