Reanalysis for Pharmacokinetic Reason [Bioanalytics]

posted by Achievwin – US, 2020-07-27 23:47 (177 d 22:59 ago) – Posting: # 21793
Views: 1,178

» I am trying to get my head around why reanalyzing a blank sample because it had values above LLOQ in the initial analysis is not considered reanalysis for pharmacokinetic reason.

IMHO most of your comments would have been anticipated and included in the Clinical and/or Bioanalytical study protocol on handling (Identifying, analyzing, and reporting) "PK repeats" there was a round table discussion in the AAPS annual meeting sometime around 2006, where three speakers discussed this issue "PK repeats- to do or not do"

Key take home message: "You have to follow the same criteria (whatever it is) which is defined before you start the sample analysis and follow tat criteria for the entire study" (NO dropping dead rat from the safety analysis)"

Hope you got my point.

AchievWin

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