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

posted by Achievwin – US, 2023-06-19 18:37 (165 d 02:25 ago) – Posting: # 23603
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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.

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