Bioequivalence and Bioavailability Forum 06:21 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

meet.shah
Junior

Jordan,
2018-09-05 09:19

Posting: # 19239
Views: 492

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

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]

Bioequivalence and Bioavailability Forum | Admin contact
19,188 posts in 4,084 threads, 1,308 registered users;
online 11 (0 registered, 11 guests [including 9 identified bots]).

The aim of science is not to open the door to infinite wisdom,
but to set a limit to infinite error. Bertolt Brecht

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by

Ing. Helmut Schütz