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RegisterClinical endpoint studies [Design Issues]
Dear all,
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? Would it be advisable to discuss with the regulatory authority the study requirements before initiating such a study?
I would be grateful for your advice.
Best regards
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? Would it be advisable to discuss with the regulatory authority the study requirements before initiating such a study?
I would be grateful for your advice.
Best regards
Complete thread:
- Clinical endpoint studiesmyy 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 studies ElMaestro 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