Loky do
★    

Egypt,
2022-06-26 17:05
(49 d 17:00 ago)

Posting: # 23091
Views: 389
 

 BMI [Regulatives / Guidelines]

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
Helmut
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Vienna, Austria,
2022-06-26 17:19
(49 d 16:45 ago)

@ Loky do
Posting: # 23092
Views: 356
 

 BMI in the protocol

Hi Loky do,

» 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, :blahblah:
Instead, state already in the protocol a realistic BMI-range for healthy subjects in your region.

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Loky do
★    

Egypt,
2022-06-29 11:11
(46 d 22:54 ago)

@ Helmut
Posting: # 23100
Views: 275
 

 BMI in the protocol

Thanks a lot Helmut for your reply ;-)
ElMaestro
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Denmark,
2022-06-29 14:44
(46 d 19:21 ago)

@ Helmut
Posting: # 23101
Views: 257
 

 BMI in the protocol

Agree with Helmut,

and I wish to point out the similarity to e.g. lab reports. When something is out of whack like SGOT a few points above the normal upper limit, the PI can always clear the subject for participation anyway, often with a relatively innocent "NCS" (or "CNS" or "OK" or "Fine" or "No problemo" etc) on source to indicate that although this is a little outside the planned range the subject is fit for trial. Same principle with the BMI and other inclusion criteria.
The decision is the investigator's.

You can be healthy without being normal, so to say.

Pass or fail!
ElMaestro
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