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Dear All,
In general, we should carry the BE study in one group of subjects,
however, there may be some reasons that we could not enroll all
subjects in the same time. In this case we need to divide our subjects
into more than one group, some researchers (particularly who do not in
the BE field) think that they could combine data from these subjects
and do the .ANOVA analysis by treating the data as they arise from
only 2 periods
However, the US-FDA Guidance for statistic state that " If a crossover
study is carried out in two or more groups of subjects (e.g., if for
logistical reasons only a limited number of subjects can be studied at
one time), the statistical model should be modified to reflect the
multigroup nature of the study. In particular, the model should
reflect the fact that the periods for the first group are different
from the periods for the second group. This applies to all of the
approaches (average, population, and individual BE) described in this
guidance"
My question is what is the statitical model that we should use in this
case?
Best Regards,
Wichittra
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The following message was posted to: PharmPK
Dear Wichittra,
see this thread:
http://forum.bebac.at/mix_entry.php?id=834
Best regards,
Helmut
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.-at-.bebac.at
web http://bebac.at/
contact http://bebac.at/Contact.htm
forum http://forum.bebac.at
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