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Registerand now that we are at it [Bioanalytics]
Hello nobody,
it is at the LLOQ the magic is needed. This is where the s:n is measured, also.
At present we have about 70 companies pursuing Tiotropium/Formoterol/Salmeterol/Fluticasone/and so forth approvals and for some of those methods we need an LLOQ of 0.1 pg/mL and not one iota less; even with the API6500 Qtrap and similar equipment this is at the border. The opportunity for assay optimizations have been exhausted (including columns, derivatization, SPE/LLE, and much mnore has been explored), the agency might not approve higher doses than a single shot per subject per period and we need to bear in mind that Cmax/LLOQ should be 20 or better.
You try and see if you can find a way to get approval for Tiotropium with e.g. 0.5 pg/mL. Good luck when meeting the agency
So, in as much as I agree with you that LLOQ should not ever be an issue, LLOQ is a persistent issue. But of course, that really isn't what this thread is all about
it is at the LLOQ the magic is needed. This is where the s:n is measured, also.
At present we have about 70 companies pursuing Tiotropium/Formoterol/Salmeterol/Fluticasone/and so forth approvals and for some of those methods we need an LLOQ of 0.1 pg/mL and not one iota less; even with the API6500 Qtrap and similar equipment this is at the border. The opportunity for assay optimizations have been exhausted (including columns, derivatization, SPE/LLE, and much mnore has been explored), the agency might not approve higher doses than a single shot per subject per period and we need to bear in mind that Cmax/LLOQ should be 20 or better.
You try and see if you can find a way to get approval for Tiotropium with e.g. 0.5 pg/mL. Good luck when meeting the agency
So, in as much as I agree with you that LLOQ should not ever be an issue, LLOQ is a persistent issue. But of course, that really isn't what this thread is all about
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Isn't it time for an open source chromatographic format ElMaestro 2018-11-04 21:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Isn't it time for an open source chromatographic format nobody 2018-11-05 09:00
- and now that we are at it ElMaestro 2018-11-05 13:53
- and now that we are at it nobody 2018-11-05 16:33
- and now that we are at itElMaestro 2018-11-05 18:19
- Transparent ruler – like in the good ol’ days Helmut 2018-11-05 20:39
- Transparent ruler – like in the good ol’ days Ohlbe 2018-11-05 22:14
- Transparent ruler – like in the good ol’ days ElMaestro 2018-11-05 22:43
- Slow down, you move too fast […] Feelin’ Groovy Helmut 2018-11-06 02:05
- Slow down, you move too fast […] Feelin’ Groovy nobody 2018-11-06 09:29
- Yes it went a little fast ElMaestro 2018-11-06 11:09
- Yes it went a little fast nobody 2018-11-06 12:05
- Yes it went a little fast ElMaestro 2018-11-06 12:10
- Yes it went a little fast Helmut 2018-11-07 16:09
- Yes it went a little fast ElMaestro 2018-11-07 16:22
- Yes it went a little fast nobody 2018-11-07 18:30
- Purpose of S:N? Helmut 2018-11-08 09:46
- Purpose of S:N? ElMaestro 2018-11-08 22:27
- Purpose of S:N? nobody 2018-11-09 10:06
- Purpose of S:N? Helmut 2018-11-09 11:34
- Purpose of S:N? nobody 2018-11-09 12:08
- Purpose of S:N? Helmut 2018-11-09 12:34
- Purpose of S:N? nobody 2018-11-09 12:08
- Purpose of S:N? Helmut 2018-11-09 11:34
- Purpose of S:N? Helmut 2018-11-09 11:26
- Purpose of S:N? ElMaestro 2018-11-09 13:16
- Purpose of S:N? nobody 2018-11-09 10:06
- Purpose of S:N? ElMaestro 2018-11-08 22:27
- Yes it went a little fast ElMaestro 2018-11-07 16:22
- Yes it went a little fast Helmut 2018-11-07 16:09
- Yes it went a little fast ElMaestro 2018-11-06 12:10
- Yes it went a little fast nobody 2018-11-06 12:05
- Yes it went a little fast ElMaestro 2018-11-06 11:09
- Slow down, you move too fast […] Feelin’ Groovy nobody 2018-11-06 09:29
- Slow down, you move too fast […] Feelin’ Groovy Helmut 2018-11-06 02:05
- Transparent ruler – like in the good ol’ days ElMaestro 2018-11-05 22:43
- Transparent ruler – like in the good ol’ days Ohlbe 2018-11-05 22:14
- and now that we are at it nobody 2018-11-05 16:33
- and now that we are at it ElMaestro 2018-11-05 13:53
- Isn't it time for an open source chromatographic format paulhurleyuk 2018-11-05 16:27
- Isn't it time for an open source chromatographic format nobody 2018-11-05 09:00
Ing. Helmut Schütz