AUC <5% of TEST geometric mean AUC [Outliers]
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!
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
Kind regards,
Stefano
Complete thread:
- AUC <5% of TEST geometric mean AUC vezz 2019-02-13 08:35 [Outliers]
- 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
- AUC <5% of TEST geometric mean AUCvezz 2019-02-13 10:08
- AUC <5% of TEST geometric mean AUC ElMaestro 2019-02-13 09:36