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RegisterBody mass index [Regulatives / Guidelines]
Dear Priyanka,
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).
❝ 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
Regards
Ohlbe
Complete thread:
- Body mass index priyanka12345 2018-11-16 08:10
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- Body mass indexOhlbe 2018-11-16 10:00
Ing. Helmut Schütz