Bioequivalence and Bioavailability Forum

Dear HS & Forum members,

This is regarding the period effect in replicate study with four period, how the period effect is calculated in replicate study, as we get only one value for period effect???

1. In typical two way crossover study, period effect is seeen comparing values of reference (or test) of period 1 Vs values of reference (or test) of period 2?
   
   or
   
   
2. In typical two way crossover study, period effect is seeen comparing PK parameter values of period 1 Vs PK parameter values of period 2 irrespective of treatment are compared?

If any of the above assumption is true how it is considered for four period fully replicate study as for period effect we should get 2 values as we give two times test and two times reference.

Thank you very much in advance.

Regards,


Ratnakar Jadhav

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Edit: Please see this post. [Jaime]