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nac
nac
Level III

Population bioequivalence approach of FDA

Created: Jan 24, 2022 05:27 AM  |  Last Modified: Jun 10, 2023 4:43 PM (1314 views)

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,

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1 REPLY 1
Mark_Bailey
Staff Mark_Bailey
Staff

Re: Population bioequivalence approach of FDA

Jan 25, 2022 04:33 PM (1280 views)  |  Posted in reply to message from nac 01-24-2022

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!

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