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RegisterPlasma sample storage as per regulatory perspective? [Regulatives / Guidelines]
Dear Alagu,
First please read the Forum policy, particularly under 'search' and 'be polite'.
Europe: nothing mentioned in any guideline. There is no requirement to keep the samples for any period of time after the end of the trial. It would make no sense to keep the samples if you don't have long-term stability data to support their use anyway.
US: AFAIK, no requirement either.
Some sponsors require the lab to keep the samples until the product gets approved, in case they get a query from regulatory agencies e.g. to analyse a metabolite in addition to the parent, etc.
First please read the Forum policy, particularly under 'search' and 'be polite'.
❝ After finishing bio-analysis for Pivotal BE study Aliquot 2 storage time period required for USA & EUROPE market?
Europe: nothing mentioned in any guideline. There is no requirement to keep the samples for any period of time after the end of the trial. It would make no sense to keep the samples if you don't have long-term stability data to support their use anyway.
US: AFAIK, no requirement either.
Some sponsors require the lab to keep the samples until the product gets approved, in case they get a query from regulatory agencies e.g. to analyse a metabolite in addition to the parent, etc.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Plasma sample storage as per regulatory perspective? alagu 2013-08-20 13:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Plasma sample storage as per regulatory perspective?Ohlbe 2013-08-20 13:51
- Plasma sample storage as per regulatory perspective? jag009 2013-08-20 18:10
- Plasma sample storage as per regulatory perspective? Ohlbe 2013-08-20 19:16
- Plasma sample storage as per regulatory perspective? jag009 2013-08-20 19:51
- Plasma sample storage as per regulatory perspective? Ohlbe 2013-08-21 10:07
- Plasma sample storage as per regulatory perspective? jag009 2013-08-20 19:51
- Plasma sample storage as per regulatory perspective? Ohlbe 2013-08-20 19:16
- Plasma sample storage as per regulatory perspective? jag009 2013-08-20 18:10
- Plasma sample storage as per regulatory perspective?Ohlbe 2013-08-20 13:51
Ing. Helmut Schütz