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Back to the forum  2018-06-21 19:50 CEST (UTC+2h)

Replicate or not? [Design Issues]

posted by Mikkabel - Belgium, 2017-02-16 12:18  - Posting: # 17068
Views: 3,273

Hello,

I am new as user of the forum (but not as a viewer) and it is my first question, so please be undestanding with me.....;-)

My company plan to perform a 4-arm PK study with two arms for two different doses of the test formulations and two arms for two different batches of the reference treatment.

Even if two different batches of the reference treatment will be used, could you please advice me if I can considered this design as a replicate design?
Furthermore, on a statistical point of view, is it correct to use the within-subject variability of the reference obtained with this design to widen the acceptance criteria for Cmax?

thank you in advance for your response,
have a nice day!

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