meet.shah
☆    

Jordan,
2018-09-05 11:19
(2454 d 00:15 ago)

Posting: # 19239
Views: 1,834
 

 Calibrators & QCs requirement in all validation runs (latest USFDA BMV) [Bioanalytics]

Post reply
Dear Members,
I am little confuse :confused: with some lines in USFDA latest BMV guidelines. It will be pleasure if anyone can solve my below question.
On Page.20 Table 1 it is mentioned that A blank (no analyte, no IS, a zero calibrator..., including LLOQ in every run. Same way for QCs on Page.21 it is mentioned that For Other Validation Runs: L, M, and H QCs in duplicates..
Does it mean that Calibrators & QCs required in Selectivity, Specificity, Sensitivity experiments?
Regards,
Meet

Edit: Category changed; see also this post #1. [Helmut]
 
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
28 visitors (0 registered, 28 guests [including 16 identified bots]).
Forum time: 11:34 CEST (Europe/Vienna)

An expert is someone who knows some of the worst mistakes
that can be made in his subject,
and how to avoid them.    Werner Heisenberg

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