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Registerno of samples above ULOQ [Bioanalytics]
Hi Ken Peh,
What do you mean when you mention you did not go for partial validation?
There are to the best of my knowledge no rules, and I think there is no big problem here as long as you have dilution integrity as part of the validation.
Diluted samples are as valid as undiluted samples.
You could run into light trouble if dilution and re-analysis of the samples in question is so labour-intensive that it makes it impossible for you to stick to your master schedule which is mainly a GLP thing cf 111m and which most regulators don't really do much about in practice. So in hindsight, perhaps you'll wish to check your planning ability and see what you can do so as to avoid too much dilution in the future.
❝ In a BE study involving 26 subjects, 20 subjects had drug level within standard calibration curve. However, the last 6 subjects had many points above ULOQ. We did not go for partial method validation as we thought the numbers would not be many. We continued the analysis until we completed all the samples.
What do you mean when you mention you did not go for partial validation?
❝ We diluted and reanalyzed these samples. The total number of reanalyzed samples is about 11% of the total number of samples.
❝
❝ How many samples are allowed to be reanalyzed ? 
Will too many repeats invalid the study ? How many is considered as too many?
There are to the best of my knowledge no rules, and I think there is no big problem here as long as you have dilution integrity as part of the validation.
Diluted samples are as valid as undiluted samples.
You could run into light trouble if dilution and re-analysis of the samples in question is so labour-intensive that it makes it impossible for you to stick to your master schedule which is mainly a GLP thing cf 111m and which most regulators don't really do much about in practice. So in hindsight, perhaps you'll wish to check your planning ability and see what you can do so as to avoid too much dilution in the future.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- no of samples above ULOQ Ken Peh 2014-08-14 17:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- no of samples above ULOQElMaestro 2014-08-14 19:28
- Pattern? Helmut 2014-08-15 04:16
- Pattern? Ken Peh 2014-08-17 20:31
- Not deserving an answer? Helmut 2014-08-17 21:27
- Combinatorics ElMaestro 2014-08-17 23:17
- Well done! Helmut 2014-08-17 23:43
- Pattern? ElMaestro 2014-08-18 23:54
- Few runs? Helmut 2014-08-19 03:04
- Few runs? ElMaestro 2014-08-19 23:32
- Few runs? ElMaestro 2014-08-20 00:07
- Hazelnut-sized brain Helmut 2014-08-20 11:27
- Few runs? ElMaestro 2014-08-20 00:07
- Few runs? ElMaestro 2014-08-19 23:32
- Few runs? Helmut 2014-08-19 03:04
- Pattern? Ken Peh 2014-08-17 20:31
Ing. Helmut Schütz