Bioequivalence and Bioavailability Forum • Reference scaled BE

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

posted by ddubins – Toronto, 2010-04-26 22:28 (5893 d 16:07 ago) – Posting: # 5241
Views: 46,217

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

Complete thread:

Reference scaled BE - FDA (and FARTSSIE update)ddubins 2010-04-26 20:28 [RSABE / ABEL]
- Reference scaled ABE - FDA d_labes 2010-04-27 08:58
  - Reference scaled ABE - FDA ElMaestro 2010-04-27 13:39
    - Factor 2 is unbiased d_labes 2010-04-27 14:30
    - Biased bonus from MoM d_labes 2010-05-04 12:10
      - Biased bonus from MoM ElMaestro 2010-05-04 12:54
        
        Mixed MoM d_labes 2010-05-04 14:40
        
        Mixed MoM ElMaestro 2010-05-04 15:08
        
        R and G, CSH and UN d_labes 2010-05-05 10:42
        
        A sailor gets confused ElMaestro 2010-05-05 11:49
        
        Confused V/Z matratzen and tips d_labes 2010-05-05 14:49
        
        superb post! ElMaestro 2010-05-05 21:32
        
        Gambling with UN d_labes 2010-05-06 11:00
        
        Mixed MoM yjlee168 2010-05-05 09:12
- Reference scaled BE - FDA (and FARTSSIE update) KR 2010-04-27 13:14
- Reference scaled BE - EMA Helmut 2010-04-27 14:58
  - Reference scaled BE - EMA ddubins 2010-04-27 17:52
    - Partial replicate design and FDA ABE code d_labes 2010-04-28 09:47
    - Reference scaled BE - EMA Helmut 2010-04-28 14:46
    - Switching - null sWR d_labes 2010-05-04 14:04
- The unknown x d_labes 2010-05-06 13:26
  - The unknown x jdetlor 2010-09-28 17:22
    - Unknown x corrected? d_labes 2010-10-01 12:14
      - Unknown x corrected? Qilex 2016-09-21 12:25
        
        Official unknown x d_labes 2016-09-21 13:22