Reference scaled BE - FDA (and FARTSSIE update) [RSABE / ABEL]

posted by ddubins  – Toronto, 2010-04-26 22:28 (5085 d 01:40 ago) – Posting: # 5241
Views: 37,116

Hi group,

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:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209294.pdf

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:

http://individual.utoronto.ca/ddubins/FARTSSIE17.xls

Best,
-Dave Dubins


Edit: Files linked. Note: Oh, wow! [Helmut]

David Dubins, Ph.D., B.A.Sc.
Associate Professor, Teaching Stream
Director, Pharmaceutical Chemistry Specialist Program
Leslie Dan Faculty of Pharmacy
University of Toronto

144 College Street (room PB802), Toronto, ON M5S 3M2
Tel. +1 416-946-5303; FAX: +1 416 978-8511

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