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Back to the forum  Query: 2017-11-18 21:32 UTC (UTC+2h)
 
Achievwin
Junior

US,
2017-10-26 14:12

Posting: # 17923
Views: 330
 

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

Folks:

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

Thanks a lot for your input

Achieve and Win
Helmut
Hero
Homepage
Vienna, Austria,
2017-10-26 17:08

@ Achievwin
Posting: # 17928
Views: 282
 

 Allowed Time gap between Cohorts in a BE study

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

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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ElMaestro
Hero

Denmark,
2017-10-26 21:01

@ Achievwin
Posting: # 17929
Views: 259
 

 Allowed Time gap between Cohorts in a BE study

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

I agree with Helmut. There is no real limit in my experience.
From a stats point of view it isn't an issue at all. Of course there are a few situations when you wish to avoid seasonal variations between cohorts (rhinitis or asthma patients etc), but you probably have volunteers?

Re. your sentence "Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.": I think it is better in practice to analyse samples after each cohort and accumulate the PK-data until the time of stats analysis.

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
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