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RegisterBA/BE study - internal standard response variability [Bioanalytics]
Dear Avinash,
The issue of IS variation has been discussed multiple times at the WRIB. This year they even had a full day on this topic, with speakers from the FDA and other regulators + industry.
I would suggest you to have a look at the White Papers of the WRIB meeting of 2015 and 2017, published in Bioanalysis, and wait for this year's to be published.
There were also some presentations at EBF meetings in the past. According to my dear friend Google some slides are supposed to be available here but I'm getting a 503 error message, dunno if it's temporary or permanent. Same slides copied there, not sure they have an authorisation for it.
The issue of IS variation has been discussed multiple times at the WRIB. This year they even had a full day on this topic, with speakers from the FDA and other regulators + industry.
I would suggest you to have a look at the White Papers of the WRIB meeting of 2015 and 2017, published in Bioanalysis, and wait for this year's to be published.
There were also some presentations at EBF meetings in the past. According to my dear friend Google some slides are supposed to be available here but I'm getting a 503 error message, dunno if it's temporary or permanent. Same slides copied there, not sure they have an authorisation for it.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- BA/BE study - internal standard response variability avinash 2018-07-11 06:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BA/BE study - internal standard response variability ElMaestro 2018-07-11 08:14
- BA/BE study - internal standard response variabilityOhlbe 2018-07-12 00:24
Ing. Helmut Schütz