BMI limits [Design Issues]

posted by Ohlbe – France, 2018-10-30 12:42 (2439 d 15:44 ago) – Posting: # 19501
Views: 4,735

Dear Amira,

❝ Are subjects with deviations up to 10% in body mass index (for example: 31.5) eligible to be enrolled in bioequivalence studies?


Deviation from what ?

What did you put in your protocol ? Either the BMI is within the limits set in the protocol and the subject is eligible, or the BMI is outside the limits and the subject is not eligible. Full stop. There is no bargaining.

If your question relates to what limits should be put in the protocol: what is written in the guideline applicable to the country where your trial will be submitted ? If the guideline sets an upper limit of 30, then you should put that limit in the protocol. Again, no bargaining.

A high BMI may not be problematic by itself on a PK or BE point of view, but you may have difficulties drawing the blood samples.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,684 registered users;
42 visitors (0 registered, 42 guests [including 22 identified bots]).
Forum time: 05:26 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5