Achievwin
★    

US,
2023-06-19 18:37
(389 d 23:31 ago)

Posting: # 23603
Views: 1,649
 

 SD crossover study with no washout any examples [Design Issues]

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.
wienui
★    

Germany/Oman,
2023-06-20 08:00
(389 d 10:08 ago)

(edited by on 2023-06-20 08:19)
@ Achievwin
Posting: # 23605
Views: 1,287
 

 SD crossover study with no washout any examples

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

❝ Any precedence or literature reference is hihgly appreciated.


Hi Achievwin,

I have found the following
https://onlinelibrary.wiley.com/doi/pdf/10.1111/1753-0407.12412
https://www.isrctn.com/editorial/retrieveFile/f3dfaa62-ea9e-4bb9-beca-c935631ea324/32769

It looks like these are all related to diabetes formulations!!!!
hope this can help.

Cheers,
Osama
Achievwin
★    

US,
2023-06-20 16:48
(389 d 01:20 ago)

@ wienui
Posting: # 23608
Views: 1,209
 

 SD crossover study with no washout any examples

Thank you so much will review and post my interpreation
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