Log in
Registertlast (Common) [Regulatives / Guidelines]
Hello nobody,
As far as I know, regulators are well aware of the publications of Getz et al. They totally get the idea aired in their papers, but they don't change their views or ask applicants to change practices.
We also need to bear in mind that it is quite common to have time point deviations on late samples, especially if they are ambulatory. Some of those are missing, even.
There is, for practical purposes, not always a crystal clear way we can speak of a meaningful last common time point regardless of how well the trial is planned and executed.
❝ So what is your solution, do you specify in the protocol/SOP that AUC0-tlast is calculated employing tlast common? Any outcries in EU? Did anybody (sponsor/reg) recognize/ask back?
As far as I know, regulators are well aware of the publications of Getz et al. They totally get the idea aired in their papers, but they don't change their views or ask applicants to change practices.
We also need to bear in mind that it is quite common to have time point deviations on late samples, especially if they are ambulatory. Some of those are missing, even.
There is, for practical purposes, not always a crystal clear way we can speak of a meaningful last common time point regardless of how well the trial is planned and executed.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- inter-batch variability? Dr_Dan 2010-08-04 10:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- inter-batch variability? Pavidus 2010-08-04 11:57
- inter-batch variability? d_labes 2010-08-04 13:58
- inter-batch variability? ElMaestro 2010-08-04 17:09
- Between study variability common for HVDs Helmut 2010-08-04 19:45
- Between study variability common for HVDs ElMaestro 2010-08-04 21:01
- Representative batches? Helmut 2010-08-04 23:42
- Representative batches? ElMaestro 2010-08-05 08:40
- Representative batches? Helmut 2010-08-05 12:30
- Representative batches? Dr_Dan 2010-08-05 08:58
- Representative batches? Helmut 2010-08-05 12:45
- Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
- Confidence intervals vs. point estimates Helmut 2010-08-06 13:20
- Confidence intervals vs. point estimators Dr_Dan 2010-08-06 14:44
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
- meta analysis? martin 2010-08-06 17:25
- meta analysis? ElMaestro 2010-08-06 17:57
- meta analysis? Helmut 2010-08-06 18:31
- meta analysis? Ohlbe 2010-08-06 23:21
- No chance against RMS? Dr_Dan 2010-08-10 12:27
- No chance against RMS? ElMaestro 2010-08-10 16:26
- No chance against RMS? Dr_Dan 2010-08-10 12:27
- meta analysis? ElMaestro 2010-08-06 17:57
- meta analysis? martin 2010-08-06 17:25
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
- Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
- Representative batches? Helmut 2010-08-05 12:45
- Representative batches? ElMaestro 2010-08-05 08:40
- Representative batches? Helmut 2010-08-04 23:42
- Between study variability common for HVDs ElMaestro 2010-08-04 21:01
- Batch-to-Batch Pharmacokinetic Variability kumarnaidu 2016-07-20 07:16
- tlast (Common) Helmut 2016-07-20 10:48
- tlast (Common) nobody 2019-02-21 15:20
- tlast (Common)ElMaestro 2019-02-21 16:32
- tlast (Common) nobody 2019-02-21 17:02
- tlast (Common) ElMaestro 2019-02-21 18:02
- tlast (Common) nobody 2019-02-21 18:17
- tlast (Common) ElMaestro 2019-02-21 18:02
- tlast (Common) nobody 2019-02-21 17:02
- tlast (Common)ElMaestro 2019-02-21 16:32
- tlast (Common) nobody 2019-02-21 15:20
- tlast (Common) Helmut 2016-07-20 10:48
- Between study variability common for HVDs Helmut 2010-08-04 19:45
Ing. Helmut Schütz