Change in ULOQ concentration [Bioanalytics]

posted by auditor – India, 2012-02-03 09:28 (4867 d 10:33 ago) – Posting: # 8048
Views: 1,557

Dear All,

In one of the validation it is observed that the ULOQ is decreased from 3000 pg/ml to 500 pg/ml. To justify this only one P&A is injected. I feel to justify this recovery and DI need to be perform again as QC level is also change accordingly.

Kindly give you suggestion on this.

Regards,

Auditor

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,675 registered users;
26 visitors (0 registered, 26 guests [including 16 identified bots]).
Forum time: 21:02 CEST (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

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