Bioequivalence and Bioavailability Forum

Hi all,

I am reading FDA's draft guidance on Loteprednol, revised June 2012.

"If using the cross-over study design and within-subject variability is a concern, the applicant may apply an appropriately designed adaptive group-sequential bioequivalence study design. For general information on this approach, please refer to Potvin et al. Sequential design approaches for bioequivalence studies with crossover designs, Pharm. Stat. 7:245-262 (2008) and Montague et al. Additional results for ‘Sequential design approaches for bioequivalence studies with crossover designs’, Pharm. Stat. 2011 Feb 10. Please note that if there is no intention to separately submit to the Agency the results of the first group, then a second group may be enrolled following analysis of data from the first group, and statistical analysis conducted using “group” in the model without using the sequential design constraints."

Whiskey Tango Foxtrot?
What does that mean for an applicant and does anyone have some insight into the logic behind it?

Note: Same passage exists in the dexa/tobi guidance document. Also revised June 2012.