Not excluding invalid data? [Study Assessment]
Hi Ohlbe,
Let me play the devil’s advocate. I think there are two worst case scenarios. (1) Further dilution fails A&P or (2) the storage cannot be extended (fails as well). Now what? All reanalysed concentrations (>ULOQ is mentioned as a reason in the BMV-GL) are not valid. Given the high variability generally observed for Cmax, the value in the other period is not relevant. Even with true F=1, Cmax might be ≤ULOQ in one period and >ULOQ in the other.
What do you think a regulator would prefer?
) but (a) would not bias the treatment comparison. Only the producer’s risk increases. IMHO, (b) contradicts all rules about using valid data only and the treatment comparison might be biased.
❝ […] I think that regulators would not see with a very positive eye the exclusion of the one subject with the highest Cmax in the whole study. Particularly if his Cmax was within range in the other period.
Let me play the devil’s advocate. I think there are two worst case scenarios. (1) Further dilution fails A&P or (2) the storage cannot be extended (fails as well). Now what? All reanalysed concentrations (>ULOQ is mentioned as a reason in the BMV-GL) are not valid. Given the high variability generally observed for Cmax, the value in the other period is not relevant. Even with true F=1, Cmax might be ≤ULOQ in one period and >ULOQ in the other.
What do you think a regulator would prefer?
- Excluding the subject and assess BE based on valid data only.
- Keep the subject though the reanalysed Cmax in one period is not valid.

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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:
- ULOQ Anand 2017-10-30 06:38 [Study Assessment]
- ULOQ Helmut 2017-10-30 10:30
- ULOQ Ohlbe 2017-10-30 10:35
- ULOQ Helmut 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
- ULOQ Helmut 2017-10-30 10:59
- ULOQ ElMaestro 2017-10-30 13:18
- Serial dilutions? Don’t! Helmut 2017-10-30 17:53