Bioequivalence and Bioavailability Forum

Dear all,

the new BE guideline recommends the use of labels with a tear-off portion on the individually packed test and reference products. Could you kindly explain me what information should be printed on this tear-off portion and what is the purpose of it? How do you archive these tear-off labels?
And more generally, how do you pack the products individually for each subject? If they come from the sponsor packed in blisters, do you divide the blister with scissors to single units and put them into an envelope with an appropriate label? Or do you put the tablets from the blisters to a bottle?

Thank you.

With best regards,

Jan