(99 d 13:01 ago)
Posting: # 23603
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.
(98 d 23:38 ago)
(edited by on 2023-06-20 08:19)
Posting: # 23605
❝ Are there any examples of single dose cross-over study with no washout period?
❝ Any precedence or literature reference is hihgly appreciated.
I have found the following
It looks like these are all related to diabetes formulations!!!!
hope this can help.
(98 d 14:50 ago)
Posting: # 23608
Thank you so much will review and post my interpreation