drug concentration <LLOQ in both periods [Study Assessment]
Dear Vidya!
Do you mean <LLOQ?
'Nil' doesn't exist in bioanalytics.
Sure, what's AUCT/AUCR = 0/0...
As is. But: try to find an explanation anyhow. Is the drug subjected to polymorphic metabolism? One example is codeine, where besides slow/fast metabolizers there is a rare subpopulation of ultrafast metabolizers. In such a case you simply don't catch the parent with an analytical method validated for a BE-study...
❝ [...] for one subject drug concentration was nil for both periods.
Do you mean <LLOQ?
'Nil' doesn't exist in bioanalytics.

❝ we excluded that subject from stastical analysis.
Sure, what's AUCT/AUCR = 0/0...
❝ How to report same in integrated (clinical) report?
As is. But: try to find an explanation anyhow. Is the drug subjected to polymorphic metabolism? One example is codeine, where besides slow/fast metabolizers there is a rare subpopulation of ultrafast metabolizers. In such a case you simply don't catch the parent with an analytical method validated for a BE-study...
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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- drug concentration nil in both periods VP 2009-10-14 09:10
- drug concentration <LLOQ in both periodsHelmut 2009-10-14 13:51
- drug concentration <LLOQ in both periods VP 2009-10-15 12:35
- drug concentration <LLOQ in both periods SDavis 2009-10-15 13:18
- drug concentration <LLOQ in both periods Helmut 2009-10-15 13:55
- drug concentration <LLOQ in both periods VP 2009-10-15 14:13
- drug concentration <LLOQ in both periods VP 2009-10-15 12:35
- drug concentration <LLOQ in both periodsHelmut 2009-10-14 13:51