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RegisterFreeze-thaw studies [Bioanalytics]
posted by Helmut 
– Vienna, Austria, 2013-09-04 15:27 (4283 d 12:41 ago) – Posting: # 11432
Views: 4,525
Hi Martin!
Do you know the initial concentration?
Nope. As en entry point see EMA’s bioanalytical GL. There the limits are the ones common for (in)accuracy / (im)precision: ±15%/15% (or ±20%/20% at the LLOQ).
❝ I have a freeze-thaw experiment where two lots are freezed and thawed for five times. For each freeze-thaw step three replicates are available. No ‘acceptance’ criteria from a biological point of view are available.
Do you know the initial concentration?
❝ Does somebody know how this kind of studies is usually analyzed? Are there
❝ any guidelines and/or papers available?
Nope. As en entry point see EMA’s bioanalytical GL. There the limits are the ones common for (in)accuracy / (im)precision: ±15%/15% (or ±20%/20% at the LLOQ).
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Freeze-thaw studies martin 2013-09-04 11:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Freeze-thaw studiesHelmut 2013-09-04 13:27
- Freeze-thaw studies martin 2013-09-04 14:03
- Freeze-thaw studies Helmut 2013-09-04 14:43
- Freeze-thaw studies martin 2013-09-04 14:03
- Freeze-thaw studiesHelmut 2013-09-04 13:27
Ing. Helmut Schütz