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In my knowledge US FDA or CPMP (UK) guidelines will not give a specific
BMI range within which the subjects should be enrolled. (However this
15% is allowed in canadian guidelines). It just says subjects should be
within 18 to 55 years of age within an acceptable body mass index range.
To get better results in bioequivalence studies we need to minimise the
variability (even though we opt for cross over design). The smaller the
range in age or BMI will help to reach this objective.
As far as your question is concerned, the investigator might have
selected that particular subject due to lack of availability of subjects
meeting the requisite criteria, at that time. If the investigator
justifies the inclusion criteria with the statement you have mentioned
before enrolling him in to the study, there should not be much problem
with reference to protocol deviations and GCP requirements (as it
becomes a planned deviation). But there is a chance that he contributes
to the variability of the pharmacokinetic data. It even may contribute
in decreasing the power of the design (a higher deviation from 15%,
which is allowedin canadian guidelines) .
Hope it may help to some extent.
Dr. Vinay Ph D, Clinical Research, Lambda Therapeutic Research,
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