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Bayesian BE Assessment [Study As­sess­ment]

posted by Ben - 2017-03-13 18:55  - Posting: # 17150
Views: 621

Dear All,

In times where Bayesian techniques come more often I was wondering about BE trials and therefore my question: Has anyone of you evaluated a BE trial using Bayesian techniques? I guess in a confirmatory setting the answer of our regulators is clear: not acceptable. Or not? Ok, maybe as a secondary analysis. What was the feedback from the agency? What kind of prior did you use? (interesting would of course be a case which is not non-informative like in [1, Section 5.9])

Experiences or ideas are much appreciated.

Thanks,
Ben.

[1] Patterson, Jones. Bioequivalence and Statistics in Clinical Pharmacology. Chapman & Hall/CRC, Boca Raton 2006.

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