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RegisterAllowed Time gap between Cohorts in a BE study [Design Issues]
posted by Helmut 
– Vienna, Austria, 2017-10-26 21:08 (3168 d 02:12 ago) – Posting: # 17928
Views: 5,005
Hi Achievwin,
Maybe this presentation gives you some ideas. The FDA uses the elastic clause “months apart” to describe a large interval.
Take care that you don’t run into issues with the validated long-term stability.
❝ 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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Allowed Time gap between Cohorts in a BE study Achievwin 2017-10-26 16:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Allowed Time gap between Cohorts in a BE studyHelmut 2017-10-26 19:08
- Allowed Time gap between Cohorts in a BE study ElMaestro 2017-10-26 23:01
Ing. Helmut Schütz