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bala ☆ Bangalore, India, 2009-01-21 09:43 (5951 d 06:50 ago) Posting: # 3081 Views: 4,251 |
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Dear All, Good day to all....  I m Balasubramanian, doing as a biostatistician for a CRO in Bangalore, India. We are doing a two treatment two sequence four period replicated study. Since this is the first time we are performing a study like this, hereby I request you to help me to find the SAS codes to claim bioequivalence (IBE & PBE) using reference scaling technique.... Please provide us with SAS codes or by guiding us how to arrive to a conclusion.. Thanks in advance — Cheers Bala |
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d_labes ★★★ Berlin, Germany, 2009-01-21 11:10 (5951 d 05:23 ago) @ bala Posting: # 3082 Views: 3,889 |
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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?  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 |
Ing. Helmut Schütz