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

posted by vezz – Erba (CO), Italy, 2019-02-13 10:08  – Posting: # 19905
Views: 1,295

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,

Stefano

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