Allowed Time gap between Cohorts in a BE study [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2017-10-26 21:08 (1979 d 11:51 ago) – Posting: # 17928
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Hi Achievwin,

❝ Are there any limitations on the maximum days allowed between different cohorts (let us say Cohort 1 and Cohort 2) in a Cross over BE study?

Maybe this presentation gives you some ideas. The FDA uses the elastic clause “months apart” to describe a large interval.

❝ Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.

Take care that you don’t run into issues with the validated long-term stability. :-D

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