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RegisterRequirement of temperature data before dosing [Study Performance]
Dear Anky,
What are the recommendation for storage of the IMP ?
If the product is to be kept refrigerated or frozen: yes, this is a problem, and I would not dose the subjects without temperature data.
If not: it depends on the recommendations (below 25°C, below 30°C, or nothing ?), on the stability data that the sponsor has on file (40°C / 70 % HR: e.g. if stable for 3 months but not 6, that's still OK; if unstable after 1 month, could be problematic) and on the duration of shipment.
What are the recommendation for storage of the IMP ?
If the product is to be kept refrigerated or frozen: yes, this is a problem, and I would not dose the subjects without temperature data.
If not: it depends on the recommendations (below 25°C, below 30°C, or nothing ?), on the stability data that the sponsor has on file (40°C / 70 % HR: e.g. if stable for 3 months but not 6, that's still OK; if unstable after 1 month, could be problematic) and on the duration of shipment.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Requirement of temperature data before dosing anky1212 2017-07-20 08:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Requirement of temperature data before dosingOhlbe 2017-07-20 09:57
- Requirement of temperature data before dosing anky1212 2017-07-20 10:21
- Requirement of temperature data before dosing Ohlbe 2017-07-20 10:24
- Requirement of temperature data before dosing anky1212 2017-07-20 11:33
- Requirement of temperature data before dosing ElMaestro 2017-07-20 12:13
- Requirement of temperature data before dosing anky1212 2017-07-20 11:33
- Requirement of temperature data before dosing Ohlbe 2017-07-20 10:24
- Requirement of temperature data before dosing anky1212 2017-07-20 10:21
- Requirement of temperature data before dosingOhlbe 2017-07-20 09:57
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