drug concentration <LLOQ in both periods [Study Assessment]
Dear Vidya!
Funny. My name is Helmut (see my signature and my profile); Vienna is the town I'm living in.
I didn't talk about active metabolites, but metabolism in general. Flurbiprofen is hydroxilated by CYP2C9; polymorphism is documented. Maybe the subject was depressed staying at the clinical site and took St. John's wort (an inducer of CYP2C9).
Again: please delete 'nil' from your (bioanalytical) vocabulary.
Simon's answer is reasonable. Some volunteers are quite good in hiding a drug during a 'mouth check'. Was this a 'new' volunteer or had you a similar experience with him/her in previous studies?
Concerning reporting: As already said, report the finding as it is. Of course nothing to calculate...
❝ Dear Vienna,
Funny. My name is Helmut (see my signature and my profile); Vienna is the town I'm living in.
❝ Drug was Flurbiprofen, as far as I know it doesn't have other active
❝ metabolite.
I didn't talk about active metabolites, but metabolism in general. Flurbiprofen is hydroxilated by CYP2C9; polymorphism is documented. Maybe the subject was depressed staying at the clinical site and took St. John's wort (an inducer of CYP2C9).

❝ During analysis, for rest of the subjects concentration were detected
❝ except one where the concentration was nil for both the periods.
Again: please delete 'nil' from your (bioanalytical) vocabulary.
❝ But my confusion is that as subject was dosed but concentration is nil,
❝ what will be the possible reason and how to report the same.
Simon's answer is reasonable. Some volunteers are quite good in hiding a drug during a 'mouth check'. Was this a 'new' volunteer or had you a similar experience with him/her in previous studies?
Concerning reporting: As already said, report the finding as it is. Of course nothing to calculate...
—
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
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 periods Helmut 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 periodsHelmut 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 periods Helmut 2009-10-14 13:51
