Log in
RegisterStudy Results [Study Assessment]
Hi VSL,
This does not correspond to the world I know. Can you show the example?
If I am not mistaken HRotter or some other guru once mentioned on this forum that a PE outside the CI is theoretically possible; from the equation for the 90% BE CI -which I hope is generally accepted- I think it is evident that the PE is not outside the CI.
The term is nuisance effect. This forum has discusssed it many times, try and search for it. Basically, it should not be too much of a worry. Those p-values correspond to a null hypothesis you are not really interested in when testing for BE.
Pre-dose levels of the analyte is, however, more tangible ground for concern.
❝ Please explain what to do if following results obtained in BE-Study:
❝ 1. Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.
This does not correspond to the world I know. Can you show the example?
If I am not mistaken HRotter or some other guru once mentioned on this forum that a PE outside the CI is theoretically possible; from the equation for the 90% BE CI -which I hope is generally accepted- I think it is evident that the PE is not outside the CI.
❝ 2. Study is passed in CI but there is significant p-value for treatment/period/sequence
The term is nuisance effect. This forum has discusssed it many times, try and search for it. Basically, it should not be too much of a worry. Those p-values correspond to a null hypothesis you are not really interested in when testing for BE.
Pre-dose levels of the analyte is, however, more tangible ground for concern.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Study Results VSL 2015-04-20 21:46 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Study ResultsElMaestro 2015-04-20 23:47
- upper CL < PE Helmut 2015-04-21 00:39
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 00:24
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 17:12
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
- PE restriction for HVDs/HVDPs Helmut 2015-04-22 16:41
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 17:12
- GMR outside the limits when using ABEL Averroes 2017-05-19 11:53
- Regulations ≠ Science Helmut 2017-05-19 14:07
- Regulations ≠ Science Averroes 2017-05-22 20:51
- Regulations ≠ Science Helmut 2017-05-19 14:07
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
- Study ResultsElMaestro 2015-04-20 23:47
Ing. Helmut Schütz