AUC <5% of TEST geometric mean AUC [Outliers]

posted by vezz – Erba (CO), Italy, 2019-02-13 10:08  – Posting: # 19905
Views: 440

Hi ElMaestro,

thank you for your prompt reply.

The information on inhalation manoeuvre (performed correctly/incorrectly, if not why, etc.) was collected in the CRF and some data were excluded due to a bad technique. For the case under discussion, no issues were reported.

Could you please expand a little bit on your suggestion related to Cmax? I think you are referring to the following recommendation included in section 4.1.7 (Bioanalytical methodology) of the EMA guideline: "The lower limit of quantitation should be 1/20 of Cmax or lower, as pre-dose concentrations should be detectable at 5% of Cmax or lower". However, it is not completely clear to me how to justify the exclusion of the period based on this statement.

Thank you again for your help!

Kind regards,


Complete thread:

 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,478 posts in 4,133 threads, 1,333 registered users;
online 18 (0 registered, 18 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 04:41 CEST

If you don’t know anything about computers,
just remember that they are machines that do exactly what you tell them
but often surprise you in the result.    Richard Dawkins

BEBAC Ing. Helmut Schütz