bioanalytics (LLOQ) [General Statistics]
Dear joyjac,
The idea in HS' post was that values below LLOQ should not be reported as numeric values but as "BLQ" (or any other abbreviation. So no value to be included in the PK analysis.
LLOQ is the lowest concentration for which you have demonstrated that you meet the requirements for precision and accuracy. Meaning that any value below LLOQ should be considered as not meeting these requirements and is therefore not reportable.
Even if you see a very nice-looking peak on your chromatogram. And even if you feel that you could achieve a lower LLOQ (which may indeed happen if you have selected your LLOQ based on what you really need for your trial, not on what your instrument can achieve, which can be significantly lower).
Regards
Ohlbe
The idea in HS' post was that values below LLOQ should not be reported as numeric values but as "BLQ" (or any other abbreviation. So no value to be included in the PK analysis.
LLOQ is the lowest concentration for which you have demonstrated that you meet the requirements for precision and accuracy. Meaning that any value below LLOQ should be considered as not meeting these requirements and is therefore not reportable.
Even if you see a very nice-looking peak on your chromatogram. And even if you feel that you could achieve a lower LLOQ (which may indeed happen if you have selected your LLOQ based on what you really need for your trial, not on what your instrument can achieve, which can be significantly lower).
Regards
Ohlbe
Complete thread:
- SR formulations hirenpharm 2007-01-20 10:05 [General Statistics]
- SR formulations - no MD study? Helmut 2007-01-22 19:09
- SR formulations - no MD study? hirenpharm 2007-01-23 18:13
- SR formulations - no MD study? Helmut 2007-01-23 18:32
- SR formulations - no MD study? hirenpharm 2007-01-23 18:13
- SR formulations velupharm 2007-01-23 12:38
- bioanalytics (LLOQ) Helmut 2007-01-23 19:59
- bioanalytics (LLOQ) velupharm 2007-01-24 05:36
- bioanalytics (LLOQ) Helmut 2007-01-24 12:40
- bioanalytics (LLOQ) joyjac 2007-05-22 02:13
- bioanalytics (LLOQ)Ohlbe 2007-05-24 23:02
- bioanalytics (LLOQ) joyjac 2007-05-22 02:13
- bioanalytics (LLOQ) Helmut 2007-01-24 12:40
- bioanalytics (LLOQ) velupharm 2007-01-24 05:36
- bioanalytics (LLOQ) Helmut 2007-01-23 19:59
- SR formulations - no MD study? Helmut 2007-01-22 19:09