dear all,Back to the Top
i would like to know in bioequivalence for ratio analysis do we need
concider log transformed data or untransformed data.
I would appreciate if someone could help me.
Dear Kanimozhi,Back to the Top
"i would like to know in bioequivalence for ratio analysis do we need
concider log transformed data or untransformed data."
The US FDA guidelines on BA-BE recommends use of log-transformed data.
For your reference I quote from the mentioned guidelines:
"IV. COMPARISON OF BA MEASURES IN BE STUDIES
An equivalence approach has been and continues to be recommended for BE
recommended approach relies on (1) a criterion to allow the
comparison, (2) a confidence interval for
the criterion, and (3) a BE limit. Log-transformation of exposure
measures prior to statistical analysis is
You may go through the entire guideline available on FDA web site, for
your better understanding.
Hope this helps.
Astron Research Ltd.
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The standard is log transformation for statistical analysis.
So back transformed difference in (log transformed) treatment means is
Dear kanimozhiBack to the Top
You need to consider log transformed data for determining Confidence
intervals in order to prove whether your product is bioequivalent with
the reference or not. Please refer the Latest FDA guidelines on
Bioavailability and bioequivalence for more details.
Ranbaxy Research Laboratories
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