BMI in the protocol [Regulatives / Guidelines]
❝ 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?
Preferable ≠ mandatory. Otherwise, Indian CROs (lower limit) or Canadian/US-based CROs (upper limit) would regularly run into recruitment issues…
❝ 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?
Extremely unlikely, esp. in a crossover study where each subject acts as its own control. I would not state in the protocol 18.5 – 30 kg/m2, have an SOP in place,
Instead, state already in the protocol a realistic BMI-range for healthy subjects in your region.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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