ratio of dose-adjusted AUCs [Regulatives / Guidelines]

posted by martin  – Austria, 2009-05-16 13:33 (5833 d 00:14 ago) – Posting: # 3686
Views: 3,526

dear hs!

what do you think about comparing dose-adjusted AUCs? on assumption of dose-proportionality the ratio of dose-adjusted AUCs should be one.

in case of more than two dose-levels, application of an adequate stepwise testing procedure (based on the closed testing approach) on dose-adjusted AUCs can help to identify the dose-range where dose-proportionality holds. this approach keeps the familywise error rate at the pre-specified alpha-level which should be more powerful than the application of the bonferroni correction.

I am looking forward to your opinion on this topic

best regards

Martin

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
79 visitors (0 registered, 79 guests [including 12 identified bots]).
Forum time: 13:48 CEST (Europe/Vienna)

My doctor gave me six months to live,
but when I couldn’t pay the bill
he gave me six months more.    Walter Matthau

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5