Method Validation [Bioanalytics]

posted by Loky do – Egypt, 2025-03-13 12:19 (71 d 09:20 ago) – Posting: # 24386
Views: 1,312

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
23,424 posts in 4,927 threads, 1,683 registered users;
56 visitors (0 registered, 56 guests [including 31 identified bots]).
Forum time: 22:40 CEST (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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