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Dear readers
With context to bioequivalence study, we are following either height -
weight chart or BMI as one of the inclusion criteria. My question is,
if we are including one or two subjects not falling in height-weight
chart or BMI, is it going to affect final outcome of Bioequivalence
study? In short, how can you corelate that deviation with final outcome
of study?
Thanks
Angus McLean Ph.D.
BioPharm Global Inc.
8125 Langport Terrace,
Suite 100
Gaithersburg,
MD 20877
301-869-1009
301-869-5737
BioPharm Global Inc.
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Dear Angus
It may be difficult to generalize but certainly it depends upon
following
1. variability of drug’s pk parameters and reasons behind the same. If
the cause of variability are first pass metabolism, solubility,
variation due to absorption,then the effect of this variability
combined with variability due to one or two OUT OF FIT volunteers may
not be very different.
2. if spread of BMI of volunteers participating the study is large then
it is going to be a major source of variation in any case, and
especially for drugs with extreme Vd values and probably extreme
protein binding proportions.
3. may be one out of 24 volunteers is marginally out of ht-wt or bmi
chart may not affect. But you need to make documentation of protocol
deviation and ascertain that you are not jeopardizing safety of
volunteer, especially if you are evaluating alpha blockers or
antipsychotics with slight alpha blocking activity or
antihypertensives, etc.
Thanks and regards
Dr.Prashant
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)