tag:blogger.com,1999:blog-3524617892004055830.post6168125810029657617..comments2024-02-29T10:02:38.091+01:00Comments on Wiekvoet: Statistical aspects of two-way cross-over studiesWingfeethttp://www.blogger.com/profile/01585623097384646816noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-3524617892004055830.post-53607464280818304662013-11-23T17:54:03.879+01:002013-11-23T17:54:03.879+01:00The admittedly funny coding arises from the educat...The admittedly funny coding arises from the educational context (denoting test and reference treatments in the two periods). I wouldn’t use it in the real world as well…<br /><br />In bioequivalence one has to follow regulatory requirements. For EMA that means all effects fixed and for the FDA a mixed effects model (with Satterthwaite’s df). Bad luck for the latter in R. Maybe (duno) the FDA accepts Kenward/Roger (available in the package pbkrtest).<br />Your resampling approach would not be acceptable to regulatory agencies, since the confidence interval is narrower – which would translate into a higher chance of approving an inequivalent treatment (increased consumer’s risk). First I guessed that it might be a convergence issue, but going form 1e3 to 1e5 improved only the PE (from 100.7082 to 100.8164); the CI is still too narrow (95.93121, 105.9267).<br /><br />All the best,<br />HelmutAnonymoushttps://www.blogger.com/profile/05929822386329203526noreply@blogger.comtag:blogger.com,1999:blog-3524617892004055830.post-4269644092777134612013-11-09T17:13:42.463+01:002013-11-09T17:13:42.463+01:00I don't know the bear package. But looking at ...I don't know the bear package. But looking at the help files, it is a complete toolbox. Starting with concentration data, ending with bio-equivalence. I feel sure that choices in dosing regime and blood sampling regime merit choices in analysis. Hence many ways in analysis are easily needed.Wingfeethttps://www.blogger.com/profile/01585623097384646816noreply@blogger.comtag:blogger.com,1999:blog-3524617892004055830.post-89896035220425900692013-11-05T00:44:47.464+01:002013-11-05T00:44:47.464+01:00The bear package can be done in so many different ...The bear package can be done in so many different ways, why we need it?Anonymoushttps://www.blogger.com/profile/16421946354318689248noreply@blogger.com