Bioequivalence and Bioavailability Forum • presention of PK and Statistics in FDA Report

presention of PK and Statistics in FDA Report [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2009-01-27 17:22 (6364 d 03:26 ago) – Posting: # 3146
Views: 3,546

Dear Pandu!

❝ As per Protocol says that PK and statistical analysis will done by

❝ un-transformed data and ln-transformed data.

So it's a stupid protocol. SCNR.

❝ But in FDA guidlines says the only present ln-transformed data in report.

Not only FDA's...

[image]
There can be only one!

❝ So which will I follow to report reparation. As we take both data sets or

❝ only one data set.

If you have a protocol, you have to follow it.
But: I would strongly advice to base the assessment of bioequivalence on log-transformed data only and to 'hide' analyses of untransformed data somewhere in an annex. :cool:

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

presention of PK and Statistics in FDA Report Pandu 2009-01-27 15:17
- presention of PK and Statistics in FDA ReportHelmut 2009-01-27 16:22
  - presention of PK and Statistics in FDA Report Pandu 2009-01-31 10:05