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Registerconcentration less than LLOQ should be addjusted to...? [Regulatives / Guidelines]
Dear Boonchai,
You are supposed to use the second option. The parameter is not AUC 0-48 but AUC 0-t, where t is the time of the last measurable concentration for that subject. Then you still have your 24 subjects to do the comparison.
If you insist on using the first option: take care when calculating AUCinf. You have to go back to AUC 0-36 for these subjects where the last measurable concentration was at 36 h, not add Clast/lambdaz to your calculated AUC 0-48 which already includes an extrapolated portion. But you may end with a situation where AUCinf will be less than your reported AUC 0-48 !
Regards
Ohlbe
You are supposed to use the second option. The parameter is not AUC 0-48 but AUC 0-t, where t is the time of the last measurable concentration for that subject. Then you still have your 24 subjects to do the comparison.
If you insist on using the first option: take care when calculating AUCinf. You have to go back to AUC 0-36 for these subjects where the last measurable concentration was at 36 h, not add Clast/lambdaz to your calculated AUC 0-48 which already includes an extrapolated portion. But you may end with a situation where AUCinf will be less than your reported AUC 0-48 !
Regards
Ohlbe
Complete thread:
- concentration less than LLOQ should be addjusted to...? boonchai_l 2009-06-18 06:03
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- concentration less than LLOQ should be addjusted to...?Ohlbe 2009-06-18 10:34
- concentration less than LLOQ should be addjusted to...? boonchai_l 2009-06-19 06:11
- concentration less than LLOQ should be addjusted to...?Ohlbe 2009-06-18 10:34
Ing. Helmut Schütz