CV, not CI [Regulatives / Guidelines]

posted by hiren379 – India, 2013-12-13 08:53 (4575 d 16:17 ago) – Posting: # 12051
Views: 3,947

Hello HS,
I have a question here
Will high intra-subject variability in Clearance and distribution have any role when Parallel design with truncation approach is implemented:confused:
Will FDA ask to demonstrate low intra-subject variability in parallel design also:confused::confused::confused:

What is the rationale for using intra-subject variability in parallel design approach?

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