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FDA population bioequivalence test PBE

Status: Acknowledged Submitted by on ‎02-16-2022 03:02 AM
1 Comment (1 New)

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

 

could someone help to add this test inside jmp? or a script for it.

1 Comment
Valerie_Nedbal
Staff
Staff
‎07-08-2025 06:41 AM
‎07-08-2025 06:41 AM
Status changed to: Acknowledged

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