Bioequivalence and Bioavailability Forum

Dear Yura

❝ Can I use design RTR | TRR for highly variable drugs?

see this post and linked post within it. Search also the forum for "extra-reference design".

Like Helmut I would not recommend this design, although it allows the estimation of the variability of the Reference and should therefore suitable for the evaluation via scaled ABE.
Since the Test is never administered in period 3 I would expect difficulties if there is a period effect.
Moreover the partial replicate design with sequences TRR|RTR|RRT is meanwhile the de facto standard if one goes with a three period design in evaluating scaled ABE for HVD/HVDP.