Route of administration other than oral for concomitant me­di­cation [Bioanalytics]

posted by Dr_Dan  – 2020-02-11 16:20  – Posting: # 21159
Views: 336

Dear qualityassurance
In case of a bioequivalence study, it also depends on whether the concomitant medication was
given obligatory to all subjects or was taken accidentally by one or maybe more subjects. In the first case, the effect for the test and the reference formulation would be the same and you do not need to argue. Otherwise, a detailed risk analysis should be carried out, which describes the estimated PK effects of the concomitant medication on the bioequivalence decision. If only a view subjects are affected a sensitivity analysis could be carried out.
I hope this helps.

Kind regards and have a nice day
Dr_Dan

Complete thread:

Activity
 Admin contact
20,465 posts in 4,298 threads, 1,414 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 17:29 CEST

Confidence is the result of hours and days and weeks and years
of constant work and dedication.    Roger Staubach

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