openpharma/mmrm

REPEATED and random intercept models are not supported?

Closed this issue · 4 comments

Dear all.

As I know, repeated models and random intercept models are also commonly used in trials.

Additionally, covariance structure TYPE=FA0(2) is also needed.

So far, I cannot apply them with mmrm. If these features are already included in mmrm, Please let me know.

Thank you.

Hi @kunghiu ,

thanks for the feedback!

Thank you for your reply, @danielinteractive .

In this FDA guidance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence-0, and many draft guidances before this one, they all use FA0(2) in proc mixed model. And this has become a standard procedure in the whole ANDA statistics. Softwares like winnonlin, they all mimic SAS and use FA0(2) structure.

However, if mmrm donot solve SAS REPEATED-like clause, only FA0(2) being added is valueless.

Thank you for your reply, @danielinteractive .

In this FDA guidance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-approaches-establishing-bioequivalence-0, and many draft guidances before this one, they all use FA0(2) in proc mixed model. And this has become a standard procedure in the whole ANDA statistics. Softwares like winnonlin, they all mimic SAS and use FA0(2) structure.

However, if mmrm donot solve SAS REPEATED-like clause, only FA0(2) being added is valueless.

Thanks @kunghiu , that is helpful - in that case I will close this issue and discussion can be continued in #300 , I will add the FDA's draft guidance snippet there