Posting: # 19239
I am little confuse 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]