Not excluding invalid data? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 18:34 (2664 d 17:19 ago) – Posting: # 17954
Views: 8,545

Hi Ohlbe,

❝ […] 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?
  1. Excluding the subject and assess BE based on valid data only.
  2. Keep the subject though the reanalysed Cmax in one period is not valid.
I’m not a regulator (:-D) 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,665 registered users;
87 visitors (0 registered, 87 guests [including 6 identified bots]).
Forum time: 11:53 CET (Europe/Vienna)

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5