Log in
RegisterClinical endpoint studies [Design Issues]
Hi myy,
What sort of drug? And is this for EU or US or other?
Yes.
❝ if a substance seems to be a problematic compound that has failed to show bioequivalence in a single-dose, two sequence and two-period crossover clinical trial is there a possibility of demonstrating bioequivalence using a clinical endpoint study? Does the clinical endpoint study have to meet the statistical BE criteria?
What sort of drug? And is this for EU or US or other?
❝ Would it be advisable to discuss with the regulatory authority the study requirements before initiating such a study?
Yes.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Clinical endpoint studies myy 2014-04-17 15:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Clinical endpoint studies Dr_Dan 2014-04-17 18:15
- Clinical endpoint studiesElMaestro 2014-04-19 13:16
- Clinical endpoint studies myy 2014-04-19 13:43
- Clinical endpoint studies ElMaestro 2014-04-19 15:12
- Clinical endpoint studies myy 2014-04-19 13:43
Ing. Helmut Schütz