What a monster! [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2018-05-21 17:47 (882 d 16:43 ago) – Posting: # 18796
Views: 6,729

Hi Ohlbe,

THX! What a monster!
At least replaced “Concentrations below the LLOQ should be reported as zeros.” in the 2013 draft by “Study samples with concentrations listed below the LLOQ should be reported as below the LLOQ (BQL).” Someone was quick enough responding within the 90 (!) days consultation period… :-D
Looked over the fence and realised that is a good idea to assess carryover. Still the whacky recovery…

» Strange, considering that the ICH M10 guideline is on its way. I somehow thought that the FDA guideline had been put on hold.

Politics strategy to strengthen the position in the upcoming negotiations? Better to have a final guidance instead of only the 2013 draft (mentioned in the ICH’s concept paper).

Dif-tor heh smusma 🖖
Helmut Schütz
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