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Hello,
In a sequential dosing design, three period. To compare PK parameters
between period, how to take care of residual effect in statistical
analysis?
Thanks
Xia
[A suitable wash-out period helps. I remember but couldn't find a
reference to a stats analysis to allow for this residual effect - db]
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Dear Xia,
I suggest to you reviewing the FDA guidance for Industry "Statistical
Approaches to Establishing Bioequivalence" (on the webpage:
http://www.fda.gov/cder/guidance/3616fnl.htm), where you would find a
subsection entitled "Carryover effect" explaining something about your
question and adding some proper references.
Anyway a proper randomization of the dose sequences help to you to avoid
troubles.
Best regards
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