Bioequivalence and Bioavailability Forum

Dear Tina,

❝ While selecting the washout period for crossover BE study, are we required to select a period of 5 half lives or 10?

For which regulatory, are you planning to submit your BE study.
For Canada, the minimum time between treatments should be the same for all subjects and, to account for variability in elimination rate between subjects, normally should be not less than 10 times the mean terminal half-life of the drug.
For FDA, an adequate washout period (e.g., more than 5 half lives of the moieties to be measured) would separate each treatment.
For ANVISA, the interval between the periods shall be of at least seven half-lives of the active ingredient and/or metabolite elimination.