Priyanka_S ☆ 2010-06-07 11:07 (5458 d 00:08 ago) Posting: # 5449 Views: 3,146 |
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Dear D_Labes, Recently FDA released Draft Guidance on Progesterone. In this SAS program for scaled average bioequivalence was given. My doubt is can we use this program for estimating BE? and also here only sequence effect was considered in ANOVA. Kindly clarify this. — Best Regards Priyanka S |
d_labes ★★★ Berlin, Germany, 2010-06-14 18:37 (5450 d 16:38 ago) @ Priyanka_S Posting: # 5511 Views: 2,610 |
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Dear Priyanka S, ❝ My doubt is can we use this program for estimating BE? Not BE but scaled average BE. Have a look on this thread. There we had some discussions about aspects of this guidance. Also they have published this SAS code to aid others I think this code is rather crude and will not work out of the box. See the "Unknown X" in the mentioned thread. Further more the code uses alpha=0.1 but I think alpha=0.05 is required for the SABE criterion. ❝ and also here only sequence effect was considered in ANOVA. The Proc GLM parts of the code have nothing to do with any ANOVA model in the usual sense. These are only a trick to avoid the coding of two consecutive loops to evaluate the double sums in the formulas for s2WR (Step 1 on page 2) and the point estimate including confidence interval of T-R via the intra-subject contrasts (differences). The latter (intra-subject contrasts T-R) is known as SENN's basic estimator approach. S. Senn "Cross-over Trials in Clinical Research" Chapter 3.6 and others, Second edition, Wiley 2002 Hope this helps. — Regards, Detlew |