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Does anyone have a practical example (with data, SAS code, and output)
implementing the IBE method recommended in the October 2000 FDA BE
guidance (and in the Stat-approach for BE guidance dated - Jan2001)?
Any help would be greatly appreciated.
Thank you in advance.
Jack Jenkins
Back to the Top
Does anyone have a practical example (with data, SAS code, and output)
implementing the IBE method recommended in the October 2000 FDA BE
guidance (and in the Stat-approach for BE guidance dated - Jan2001)?
Any help would be greatly appreciated.
Thank you in advance.
Jack Jenkins
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Jack,
WinNonlin 3.2, due out shortly, will have individual bioequivalence analysis
capability. It will analyze RTRT/TRTR, Balaam's, RTR/TRT, and other designs.
For an example of the analysis, see
http://209.24.28.60/lit/be_ap_note_v1-2.pdf
The algorithm complies with the FDA Jan2001 guidance. If you have further
questions, please don't hesitate to write to me.
Russell Reeve, PhD
Scientific Software Strategist
email: rreeve.aaa.pharsight.com
phone: 919-852-4615
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