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Dear List,
We have conducted the BE for a class 2 drug which has an intra subject
CV of 12 %. The study was a two way cross over study in Fasting and
Non-Fasting Conditions.
In the study under non-fasting conditions (30 subjects) we have one
subject who is showing significantly higher T/R ratio.
The range for the T/R for the other 29 subjects is 75.29 - 192.64,
while for 1 subject it is 269.9.
The FDA Guidance "Statistical approaches to establishing BE", Section :
Outlier consideration: Also makes a reference to effect of
significantly high T/R ratio.
In this situation is it possible to delete / disregard this particular
subject as an OUTLIER.
Your feedback will be highly appreciated.
Thanks in advance
Kamala Yadav
Assistant Group Leader
Astron Research Limited
Ahmedabad, India
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Dear Kamla Yadav
This is in context to your query, you need to apply outlier detection
test
for the values, which you suspects as outlier. and from the regulatory
point of view, you have to have SOP for the same.
Regards
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The following message was posted to: PharmPK
Dear Kamala Yadav,
in the absense of any acceptable clinical explanation why your subject
would
have an exceptionally high or low T/R ratio (e.g. vomiting), you could
do a
statistical test for detection of outliers; nevertheless, experience
tells
that the Agency will always require you to present BE-statistics based
on
both datasets, i.e., including and excluding the outlier.
best regards
Erik Mannaert,
Assoc. Dir. Clin PK
Johnson & Johnson PRD
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