Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by Obinoscopy  – USA, 2020-07-16 19:48 (275 d 04:06 ago) – Posting: # 21723
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Hi Ohlbe

» Confirming the presence of the analyte in a pre-dose sample could be relevant for other types of studies (and even worse, finding analyte in a placebo-treated subject, or animal in a TK study).

Besides non-BE studies, I also noticed that reanalysis to confirm the presence of the analyte in a pre-dose sample is allowed by some BE assessors. Do you think those group of BE assessors are inconsistent? I ask this because, the same assessors will not accept reanalysis of post-dose samples to correct an irregular PK profile.

Scopy

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