Bioequivalence and Bioavailability Forum

Dear Forum members,

I have a query regarding the calculation of AUC in BA/ BE study, which method should be used/ generally recommended by regulatory authorities?

As one of our sponsor wants AUC to be calculated by Linear/Log Trapezoidal rule instead of linear trapezoidal by which we generally do the analysis. After referencing it was found that there are following 4 methods (may be more?) by which we can calculate AUC:

1. Linear Trapezoidal
   
2. Linear/Log Trapezoidal
   
3. Linear Trapezoidal with Linear/Log Interpolation and
   
4. Linear Up and Log down Method

Which of the method is more accurate and/or recommended by regulators or any regulatory guideline specifying about this? Also what is the difference between all these methods?

Any information relating to this will be highly appreciated.

Thanking you in advance.

Ratnakar

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Edit: Category changed. [Helmut]