Bioequivalence and Bioavailability Forum

Dear Jasmin!

❝ Dear Sir...

Jaime is enough

❝ which condition any regulatory wants Clinical end point study?

Generally it's a double blind three-armed parallel study (Test-Reference-Placebo) in a patient population according to the labeled dosing of the reference; trial design and endpoints should be similar to the NDA. You will need the placebo arm to validate the study.
For details see this presentation.

❝ is there any specific criteria or product category in Clinical end point

❝ study?

According to my knowledge a clinical endpoints BE study is the 'last retreat' - where everything else fails, i.e., conventional BE or a BE study based on pharmacodynamic (surrogate) endpoints.