PharmPK Discussion - Ratio analysis for bioequivalence

PharmPK Discussion List Archive Index page

On 26 Jul 2004 at 18:20:54, "Kanimozhi" (kanimozhi.aaa.gvkbio.com) sent the message

dear all,
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.
thanking you,
kanimozhi.A

Back to the Top

On 27 Jul 2004 at 17:44:52, "Hitesh maheshwari" (hmaheshwari.-at-.astron-research.com) sent the message

Dear Kanimozhi,
"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
comparisons. The
  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
  recommended."
You may go through the entire guideline available on FDA web site, for
your better understanding.
  Hope this helps.
Regards,
  Hitesh Maheshwari
Astron Research Ltd.
  Ahmedabad, India

Back to the Top

On 27 Jul 2004 at 18:26:03, Berber Snoeijer (bsnoeijer.at.biometricsupport.nl) sent the message


The standard is log transformation for statistical analysis.
So back transformed difference in (log transformed) treatment means is
your
ratio.
Kind regards,
Berber Snoeijer

Back to the Top

On 27 Jul 2004 at 20:46:58, tausif Ahmed (mailtaus.-at-.yahoo.com) sent the message

Dear kanimozhi
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.
"
Regards
Tausif Ahmed"
Research Scientist
Ranbaxy Research Laboratories
India

Back to the Top

Want to post a follow-up message on this topic? If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Ratio analysis for bioequivalence" as the subject

PharmPK Discussion List Archive Index page