priyanka12345
☆    

India,
2018-11-16 08:10
(939 d 04:17 ago)

Posting: # 19633
Views: 1,852
 

 Body mass index [Regulatives / Guidelines]

Dear All,

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.


Regards,
Priyanka:-)


Edit: title changed to lower case. Please don't SHOUT ! [Ohlbe]
Ohlbe
★★★

France,
2018-11-16 10:00
(939 d 02:28 ago)

@ priyanka12345
Posting: # 19635
Views: 1,535
 

 Body mass index

Dear Priyanka,

» 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)

and

We also recommend that any restrictions on admission into a study be based primarily on safety considerations (lines 150-151).

Regards
Ohlbe
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