Bioequivalence and Bioavailability Forum

Dear Jasmin,

although I'm not Helmut (1350 km SE of Vienna), I dare answering as well.

❝ The pharmacodynamic BE study and Clinical end point BE study, both study

❝ are same or not.

No, they aren't.

❝ if not, what is the difference between both study?

See this thread, and this post as well.

A nice example are statins: the pharmacodynamic effect(s) are lipid-lowering (decrease in chloesterol, LDL, triglycerides, increase in HDL), whereas the clinical endpoints are based on survival rates (heart attack, stroke, peripheral vascular disease).

❝ what is the suitable study design for above study?

Generally parallel groups of patients; main difference is the samples size. For the statin-example a PD study would need dozens to hundreds of patients, whereas a study based on clinical equivalence would need many, many thousands (since the efficacy/safety studies of verum vs. placebo already needed such a high number).

On the other hand, if the desease is chronic and stable (like asthma), a washout reestablishing the orginal state, even a cross-over study in less than 50 patients may be considered.