Report as BLQ [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2018-06-29 21:00 (885 d 02:08 ago) – Posting: # 19001
Views: 1,969

Hi John!

» » » As per the Bioanalytical guidance of FDA, all values <LLQ should be declared as zero.
» » No more – see this thread. For the other points I agree with Ohlbe.
» I have never seen values below LLQ declared as 0 in any reports. :confused:

Lucky you. Was indeed stated in the FDA’s 2013 draft. Bizarre. Was a big issue at the first Crystal City (aka Arlington I) conference in 1990. People were shouting at each at other. It was very strange that “zero” reached out from the grave in the draft…

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Helmut Schütz

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