Truncted AUC, or AUCinf, which one [Design Issues]
Hi again ssussu,
Well... it would be a bit unusual to this often when the drug generally has an excessive long half-life but OK it might happen. Between-subject variability etc.
You may need to invest at least 90 seconds of your time in figuring this one out with pen and paper. You have some subjects that go below the LLOQ, which means they comfortably display an elimination phase. From those subjects you can routinely derive an elimination constant and extrapolate AUClast (least measurable) to AUCinfinity. This is where you sadly need to invest this obscenely large amount of your precious time: use the same logic and jommetry and extrapolate areas to 72 hrs. in stead of infinity. You'll end up with a full data listing of AUC72 estimates, and Bob's your uncle.
Good luck.
❝ Then if I choose truncated AUC0-72 instead of AUClast and AUCinf in the protocol,while most of the subjects half-life is not long enough (i.e 18hr) , actually, in this situation, it is possible the time point of 72hr sample concentration is BQL or can not be detected, then what I shoud do?
Well... it would be a bit unusual to this often when the drug generally has an excessive long half-life but OK it might happen. Between-subject variability etc.
You may need to invest at least 90 seconds of your time in figuring this one out with pen and paper. You have some subjects that go below the LLOQ, which means they comfortably display an elimination phase. From those subjects you can routinely derive an elimination constant and extrapolate AUClast (least measurable) to AUCinfinity. This is where you sadly need to invest this obscenely large amount of your precious time: use the same logic and jommetry and extrapolate areas to 72 hrs. in stead of infinity. You'll end up with a full data listing of AUC72 estimates, and Bob's your uncle.
Good luck.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- long half life drug bioequivalence study design ssussu 2017-08-16 11:45 [Design Issues]
- long half life drug bioequivalence study design ElMaestro 2017-08-16 12:53
- long half life drug bioequivalence study design ssussu 2017-08-17 10:18
- Truncted AUC, low variability Helmut 2017-08-16 14:18
- Truncted AUC, or AUCinf, which one ssussu 2017-08-17 10:15
- Truncted AUC, or AUCinf, which oneElMaestro 2017-08-17 10:47
- Truncted AUC, or AUCinf, which one ssussu 2017-08-18 07:13
- Truncted AUC, or AUCinf, which oneElMaestro 2017-08-17 10:47
- Truncted AUC, low variability jag009 2017-08-17 23:50
- Truncted AUC, or AUCinf, which one ssussu 2017-08-17 10:15
- long half life drug bioequivalence study design ElMaestro 2017-08-16 12:53