Bioequivalence and Bioavailability Forum

Hi Mittyri,

❝ […] when your new package AdaptiveBE will be available for comprehensive testing?

The package is still in its infancy (currently only crossover adaptive sequential designs with sample size re-estimation) are covered. Parallel only partly. Still a lot to be done:

• classical group sequential designs (optional alpha adjustment if the information time deviates from the planned one due to dropouts)
  
• GSDs with blinded and unblinded sample size re-estimation

There is so much confusion amongst regulators that I will wait for the GBHI which starts tomorrow. 32°C in Washington today. Heated debates expected.