Bioequivalence and Bioavailability Forum

Hi Clarc,

❝ Our statistical software doesn't permit scaling, only widening to 0.75-1.33. The design is a fully replicated TRTR/RTRT design.

May I guess: Kinetica? If yes, AFAIK you cannot evaluate replicate designs at all.

❝ Can I define in the protocol a widening to 0.75-1.33,

You could, but it will not be accepted…

❝ or I have to perform a reference scaled bioequivalence?

Yes – see Dr. Gunasakaran’s post above. Don’t forget two obstacles:

• A sound justification that a wider difference in C_max is clinically irrelevant.
  
• A justification that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers.