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RegisterDifferent strengths – different ISV? [Power / Sample Size]
Dear All,
Are there any "rules of thumb" about the ISV prediction for a study with a new strength?
For exapmle, the formulation 50mg is registered and we're going to conduct the study with the formulation 100 mg.
The drug has linear PK to 120 mg according to the literature.
Could we plan our study with ISV derived from the previous data? Is it safe enough?
Thanks in advance!
Are there any "rules of thumb" about the ISV prediction for a study with a new strength?
For exapmle, the formulation 50mg is registered and we're going to conduct the study with the formulation 100 mg.
The drug has linear PK to 120 mg according to the literature.
Could we plan our study with ISV derived from the previous data? Is it safe enough?
Thanks in advance!
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Different strengths – different ISV?mittyri 2014-12-21 18:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different strengths – different ISV? ElMaestro 2014-12-21 20:42
- Different strengths – different ISV? Helmut 2014-12-22 03:07
- Different strengths – thanks for advice mittyri 2014-12-22 20:33
- Planning the study based on the previous results mittyri 2015-02-11 19:23
- Planning the study based on the previous results ElMaestro 2015-02-11 20:29
- Conservatism Helmut 2015-02-12 13:31
- Different strengths – different ISV? Helmut 2014-12-22 03:07
- Different strengths – different ISV? ElMaestro 2014-12-21 20:42
Ing. Helmut Schütz