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RegisterULOQ [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2017-10-30 11:59 (2363 d 08:00 ago) – Posting: # 17950
Views: 7,919
Hi Ohlbe,
Really? Let’s assume that the subject with concentrations >ULOQ is observed in the last batch and we are already close to the validated long-term stability. Even if we revalidate with a higher dilution, we may exhaust the storage interval – resulting in unacceptable results as well. In such a case we have to exclude the subject.
❝ You can't exclude subjects or data points because they are ULOQ: the ULOQ result would be the Cmax for that subject. If you exclude the data, you will bias the outcome of the study.
Really? Let’s assume that the subject with concentrations >ULOQ is observed in the last batch and we are already close to the validated long-term stability. Even if we revalidate with a higher dilution, we may exhaust the storage interval – resulting in unacceptable results as well. In such a case we have to exclude the subject.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- ULOQ Anand 2017-10-30 06:38 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ULOQ Helmut 2017-10-30 10:30
- ULOQ Ohlbe 2017-10-30 10:35
- ULOQHelmut 2017-10-30 10:59
- ULOQ Ohlbe 2017-10-30 15:10
- Not excluding invalid data? Helmut 2017-10-30 17:34
- Excluding invalid data Ohlbe 2017-10-30 18:03
- Not excluding invalid data? Helmut 2017-10-30 17:34
- ULOQ Ohlbe 2017-10-30 15:10
- ULOQHelmut 2017-10-30 10:59
- ULOQ ElMaestro 2017-10-30 13:18
- Serial dilutions? Don’t! Helmut 2017-10-30 17:53
Ing. Helmut Schütz