BMI [Regulatives / Guidelines]

posted by Loky do – Egypt, 2022-06-26 17:05 (47 d 22:02 ago) – Posting: # 23091
Views: 385

Dears

EMA bioequivalence guidelines states for BMI "subjects preferably have a Body Mass Index between 18.5 and 30 kg/m2", does stating "preferably" mean it is accepted to have a minor deviation from this limits? so if I have a 5% accepted deviation in my internal SOPs for BMI, and allowed 2 subjects to enter the BE trial with this deviation, PI approved this deviation, what is the consequences while submitting to different authorities (especially to EMA), is it possible to reject the trial because of this deviation?

Thanks in advance

Complete thread:

UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 12 (0 registered, 12 guests [including 9 identified bots]).
Forum time: Saturday 15:07 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