BMI [Regulatives / Guidelines]

posted by Loky do – Egypt, 2022-06-26 19:05 (750 d 11:41 ago) – Posting: # 23091
Views: 1,994

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

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