Back to the Top
The FDA just recently posted a draft individual product bioequivalence recommendation for progesterone capsules, which provides useful SAS code for their reference-scaled approach. It goes in to extremely useful detail:
This is a critical read for anyone using the FDA's reference-scaled approach.
I updated my sample size program, FARTSSIE, incorporating the EMEA reference-scaled and FDA reference-scaled methods into the "Bioequivalence, Replicate" spreadsheet:
I have also posted this message on Helmut Schutz's BA/BE forum.
David Dubins, Ph.D., B.Eng.
Instructor and Laboratory Coordinator
Leslie Dan Faculty of Pharmacy
University of Toronto
144 College Street Toronto, Ontario M5S 3M2
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Reference-Scaled Approach - FDA" as the subject
Support PharmPK by using the
Copyright 1995-2011 David W. A. Bourne (firstname.lastname@example.org)