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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.
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