Bayesian BE Assessment [Study Assessment]
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.
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.
Complete thread:
- Bayesian BE AssessmentBen 2017-03-13 18:55 [Study Assessment]
- Bayesian BE Assessment DavidManteigas 2017-03-14 11:45