SAS Codes for IBE and PBE [Software]

posted by d_labes  – Berlin, Germany, 2009-01-21 11:10 (5951 d 10:21 ago) – Posting: # 3082
Views: 3,889

Dear Bala(subramanian),

have a look at the code given in the book

Jones/Kenward
Design and Analysis of Cross-Over Trials
Chapman/Hall 2003
Chapter 7 Bioequivalence trials

You may also find this code here on the 'net of nets' in a paper by
William F. McCarthy
An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review
I have a question: Why do you need PBE/IBE? :ponder:
To my knowledge no regulatory agency around the world requests this.
Even not FDA, irrespective from the fact that PBE/IBE are mentioned in their Statistical guidance (Jan 2001).
Due to an extensive debate in the 1990’s and early 2000's these forms of BE testing are revoked in the FDA guidance "Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations" (2003) which reinstates average bioequivalence as the recommended method of analysis.
Thus to my opinion PBE/IBE are only of historical interest.

Regards,

Detlew

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