Pharmacokinetic Repeats [Bioanalytics]
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.
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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Use of subject samples for trials manusyriac 2010-09-28 18:14
- Pharmacokinetic RepeatsHelmut 2010-09-28 18:23
- Pharmacokinetic Repeats manusyriac 2010-09-29 04:56
- Aberrant results Helmut 2010-09-29 21:37
- Aberrant results manusyriac 2010-10-05 16:47
- Aberrant results Helmut 2010-09-29 21:37
- Pharmacokinetic Repeats manusyriac 2010-09-29 04:56
- Pharmacokinetic RepeatsHelmut 2010-09-28 18:23
