meet.shah ☆ Jordan, 2018-09-05 11:19 (2030 d 23:30 ago) Posting: # 19239 Views: 1,350 |
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Dear Members, 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? Regards, Meet Edit: Category changed; see also this post #1. [Helmut] |