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

posted by meet.shah – Jordan, 2018-09-05 09:19 (956 d 12:28 ago) – Posting: # 19239
Views: 1,020

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?

Edit: Category changed; see also this post #1[Helmut]

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,508 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Sunday 21:47 CEST (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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