Marcel-Duclos Efoudebe
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Belgium,
2017-09-14 18:31
(2386 d 17:07 ago)

Posting: # 17809
Views: 3,932
 

 Study population in biostudies in the EU: mixed or not? [Regulatives / Guidelines]

Good evening to everyone.
I have a question related to the study population to be enrolled for a Bioequivalence study. Up till now, I was confident on the fact that, at least in the EU (I know the FDA thinks differently), the EMA guideline did not request the study population to be mixed (male and female). But at the moment, we are planning a biostudy in Jordan, and given 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?
Thanks.

Regards,

Marcel
Helmut
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Vienna, Austria,
2017-09-15 17:26
(2385 d 18:12 ago)

@ Marcel-Duclos Efoudebe
Posting: # 17811
Views: 3,364
 

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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?

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ElMaestro
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Denmark,
2017-09-15 20:46
(2385 d 14:52 ago)

@ Marcel-Duclos Efoudebe
Posting: # 17812
Views: 3,311
 

 Study population in biostudies in the EU: mixed or not?

Dear marcel,

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


As far as I have been told this is a slight anomaly related to some rules that have little to do with GCP or regulatory science. If I got it right it is an equal opportunity issue. I was told CRO's in Jordan cannot in a straightforward and legal manner go out and invite only male participants for a study on a drug taken by both genders. Something like that.

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No, not Harrison.:-D

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