Not excluding invalid data? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 17:34  – Posting: # 17954
Views: 5,574

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.

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,134 posts in 4,245 threads, 1,385 registered users;
online 12 (0 registered, 12 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 01:49 CET

A Camel is a Horse designed by committee.    Anonymous

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