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

posted by meet.shah – Jordan, 2018-09-05 09:19 (751 d 23:59 ago) – Posting: # 19239
Views: 979

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
21,076 posts in 4,394 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 09:19 CEST (Europe/Vienna)

For every fact
there is an infinity of hypotheses.    Robert M. Pirsig

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