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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:
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Ing. Helmut Schütz