Revalidation? [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-12-18 17:40 2a02:8388:6bc2:ce80:6c4e:e4df:42f4:6510 – Posting: # 21000
Views: 354

Hi Mittyri,

» […] approach when the method is revalidated taking into account Cmax values of that subjects (LLOQ should be less than 5% min Cmax of those) and then the affected volunteers are reanalyzed (of course till the moment of database lock). What do you think?

Yes, why not? As long as the data are not unblinded, it should not hurt. However,

» Recently we submitted a BE study to EU…

(my emphasis)

Hence, it can be just another kind of sensitivity analysis.


Posting # 21,000. :-D

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
20,237 posts in 4,258 threads, 1,397 registered users;
online 9 (1 registered, 8 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 10:37 CET

Science may set limits to knowledge,
but should not set limits to imagination.    Bertrand Russell

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