Bioequivalence and Bioavailability Forum

Dear Phoenix-users,

I updated the templates for the EMA’s ABEL (detailed description and download at Certara’s Phoenix WNL basics Forum).

• New supported designs: RTTR|TRRT, RTR|TRT, and RTT|TRR.
  
• Checks whether at least 12 subjects are in the sequence RTR (RTR|TRT design) or TRR (RTT|TRR design) as required in the Q&A document Rev.12.
  
• Removed the meaningless CV_wT estimated in a partial replicate design by ‘Method C’ from the output.

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Edit: We (mittyri, Detlew, and myself) realized that the EMA’s SAS-code given in the Q&A document for Method B, i.e.,

proc glm data=replicate;
class formulation subject period sequence;
model logDATA= sequence period formulation;
random subject(sequence);
estimate "test-ref" formulation -1 1 / CL alpha=0.10;
run;

does not specify in the model statement how the degrees of freedom should be estimated. Hence, SAS falls back to its default ddfm=CONTAIN. It seems that in Phoenix this is equivalent to Residual.
If you are using previous versions of the templates: Navigate in the sub-workflow Analysis|Standard Average BE|Other Methods to object BE Method B log and in the tab General Options change Degrees of Freedom from ⦿ Satterthwaite to ⦿ Residual.