Reanalysis if possible [Regulatives / Guidelines]

posted by jag009  – NJ, 2012-03-30 15:06 (3586 d 16:00 ago) – Posting: # 8354
Views: 8,494

Hi Helmut,

» OK, but if ever possible perform a reanalysis in duplicate. If the value was not too far away from the LLOQ it may have been pure chance as well.

Thanks. 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.

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?

Thanks

John

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