Bioequivalence and Bioavailability Forum 13:01 CET

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Put the sickle to the corn [General Sta­tis­tics]

posted by Helmut Homepage - Vienna, Austria, 2018-02-13 12:45  - Posting: # 18412
Views: 5,208

Hi Nastia,

» I didn't want to doubt into results of your study,

No worries. I was curious myself.

» just wanted to point out that the results of miscorrelation between Cmax and AUC should be more dependent on the features of the specific study than on the drug itself.

Or the dose regimen (as Relaxation suspected)?

» […] is sampling time is adequate but comparing to the less rapid drug the difference in 30 minutes in elimination phase could give sufficiently more error in calculating AUC (one day for jinn as thousand years for man)?

:-D

» The last question about it: what was the mean T1/2 (from these abrupt profiles I may suspect less than known in literature 20 minutes)?

Linear plot with enlarged time scale:

[image]

Your wish is my command. Data cemetery:
     tlag        tmax        t½         Cmax          AUCt           AUCext
T  5 (0, 5)  40 (30, 57) 
22 (6.5)  5.36 (24.3)  6.03 (15.6)  6.37 (5.81, 6.94)
R  5 (0, 5)  35 (30, 50) 
23 (5.2)  5.03 (25.9)  5.48 (21.0)  5.45 (4.89, 6.73)

tlag, tmax minutes; median (quartiles)
t½         minutes; harmonic mean (jackknife SD)
Cmax       µg/mL; geometric mean (CV%)
AUCt       h×µg/mL; geometric mean (CV%)
AUCext     100(AUCt–AUC)/AUC; median (quartiles)

Cheers,
Helmut Schütz
[image]

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