>6 sources of matrix [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2012-03-30 15:16 (3586 d 15:08 ago) – Posting: # 8355
Views: 8,490

Dear John!

» Yes the lab did reanalysis and came to the same conclusion (as per their SOP). It's just kind of strange to see value at 0 on period 1 that's all.

OK, at least you know now that it wasn’t pure chance but at true interference.

» Have you seen CROs which go the full length and pre-screen subjects for exposure to the study drug prior to the first dosing day?

Only once (in 30+ years) – drug was Δ9-THC. :smoke:
Another time I came across a very difficult ligand-binding assay where matrix effects were common. During method development the CRO screened ~60 subjects and in validation another 30.

Dif-tor heh smusma 🖖
Helmut Schütz

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