Method Validation [Bioanalytics]

posted by Loky do – Egypt, 2025-03-13 12:19 (119 d 05:01 ago) – Posting: # 24386
Views: 2,623

Dears
Appreciate your advice
What are the potential implications of mistakenly designing the QC high at 70% of the upper limit and analyzing study samples based on this? Would re-validation and reanalysis of all samples be required, or could this deviation be accepted by regulatory authorities?

Thanks in Advance
LD

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,680 registered users;
39 visitors (1 registered, 38 guests [including 8 identified bots]).
Forum time: 18:21 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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