Bioequivalence and Bioavailability Forum

Peers:

Are there any examples of single dose cross-over study with no washout period?

Hypothetical case: in a single dose study of an extended release dosage form concentration at last time point is less than 5% of the Cmax or pre-dose concentration to Cmax ratio is less than 5%. Will this be a good reason for not having washout between two periods?

Note: Bioequivalence guidance states if pre-dose concentrations are less than 5% Cmax the concentrations can be used without any adjustment.

Any precedence or literature reference is hihgly appreciated.