topic Re: Population bioequivalence approach of FDA in Discussions

Population bioequivalence approach of FDA

nac — Sat, 10 Jun 2023 23:43:05 GMT

Dear all,

FDA has a guidance for in vitro bioequivalence of products between test and reference. The name of this statistical test is Population bioequivalence. Please find test details below link; https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf

Is there anyone help for calculation of this test by using jmp?

BR,

Re: Population bioequivalence approach of FDA

Mark_Bailey — Tue, 25 Jan 2022 21:33:29 GMT

JMP added hypothesis tests for equivalence over many versions. The Population Bio-equivalence test is not currently implemented, though. Some might study the paper that describes this test and the calculations, and then write a script for JMP, but it would have to be validated.

In the meantime, you might go to the Wish List area. Search for a suggestion to add this test and if you find one, vote for it (kudos). If you do not find one, then add your own!