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Hi PK Colleagues
In dose proportionality BA study (2X2 design) in which Formulation A
(11.08 mg X 1 tablet) Vs Formulation B (11.08 mg X 2 tablet) is
compared. It is suggested that the before statistical analysis the PK
of formulation A which was given as one tablet should be double the
plasma concentration than run the PK, and than compare with
Formulation B for 90% CI and other statistical analysis.
What Statistical test should be used to conclude dose proportional?
Will a conventional Statistical analysis for 2X 2 design will be
enough to prove this.
Is their any additional guidance for the same?
Can you please put some light on this issue?
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