Bioequivalence and Bioavailability Forum

Hi Marcel,

❝ […] our usual practice of enrolling only male subjects, the CRO recommended not to mention this in the study title (“healthy volunteers”, instead of “healthy male volunteers”), arguing that they have received the following question from an EU authority (Italy): “The selection of exclusively male subjects in the bioequivalence study should be adequately justified”

❝ My question is: do you know if there has been any regulatory change on that field which could explain such a question?

That’s very strange indeed. Never came across that. I always preferred to include both sexes in my BE studies (lower testosterone levels in the ward lead to a calmer atmosphere and bioanalysts love the lower volume of distribution of females). No problem in hundreds of them.
In Sep 2007 I received a response from the BfArM (my translation):

“The proposed participation of healthy, female volunteers of childbearing age in this phase I trial generally has to be justified, as the applicant apparently does not want to examine any gender-specific differences and the investigational products are contraindicated during pregnancy. A comparison between male and female subjects is not provided in the chapter statistics.”

Since then: Males only, stated as such in the title, no justification given, no problems.
BTW, does the Jordanian CRO assume that agencies assess protocols only be the title?