Pharmacokinetic Repeats [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2010-09-28 20:23 (5746 d 22:31 ago) – Posting: # 5946
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Dear Manusyriac,

it depends on the country you are aiming at. In the U.S. and in Canada, it's acceptable to reanalyse samples (so-called 'Pharmacokinetic Repeats' - you have to have an SOP for that; you cannot simply reanalyse samples because you don't like the result), whereas the EMA definitely does not like this (to say it politely). Hint: Search the Forum for 'pharmacokinetic repeat', 'reanalysis', etc.

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