(1841 d 11:28 ago)
Posting: # 19633
Is there any fixed range of BMI (body mass index) for Bio equivalence studies conducted for USFDA submissions, is it 18.5 to 24.9. If so I request you to provide appropriate guidance for this.
Edit: title changed to lower case. Please don't SHOUT ! [Ohlbe]
(1841 d 09:38 ago)
Posting: # 19635
❝ Is there any fixed range of BMI (body mass index) for Bio equivalence studies conducted for USFDA submissions
No, neither in the currently applicable guideline, nor in the drafts for ANDA and NDA/IND.
The ANDA drafts even states that
In vivo BE study subjects should be representative of the general population, taking into account age, sex and race (lines135-136)
We also recommend that any restrictions on admission into a study be based primarily on safety considerations (lines 150-151).