Hi All,

 

I just want to clarify myself about Dose proportionality studies. I have following specific queries (may be silly):

1. From the literatures I studied, I observed that Dose proportionality assessment has done only in Dose escalation studies. Is the dose proportionality assessment always done in Dose escalation studies? or separate sutdies can be planned?

 

2. If we able to establish Dose proportionality then how does it affect the dose selection in Phase II trial? If we failed to establish dose proportionality then also how does it affect dose selection in phase II trial?

 

Please help me out.

 

Regards

Madan Kundu