Bioequivalence and Bioavailability Forum • AUC <5% of TEST geometric mean AUC

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

posted by vezz – Erba (CO), Italy, 2019-02-13 11:08 (1500 d 12:01 ago) – Posting: # 19905
Views: 2,449

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 C_max? 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 C_max or lower, as pre-dose concentrations should be detectable at 5% of C_max 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,

Stefano

Complete thread:

AUC <5% of TEST geometric mean AUC vezz 2019-02-13 08:35
- AUC <5% of TEST geometric mean AUC ElMaestro 2019-02-13 09:36
  - AUC <5% of TEST geometric mean AUCvezz 2019-02-13 10:08
    - AUC <5% of TEST geometric mean AUC ElMaestro 2019-02-13 12:09