Bioequivalence and Bioavailability Forum

3-period full replicates [Design Issues]

posted by Helmut  – Vienna, Austria, 2020-07-20 10:04 (25 d 17:30 ago) – Posting: # 21757
Views: 430

Hi Loky do,

» I think some countries like ours are very traditional in following guidelines,…

Agree. But the Egyptian GL of 2017 in Section 3.2 recommends the EMA’s approach and not the FDA’s. That’s not a different league but a different sport. For the SAS-codes recommended by the EMA see the Q&A document. Alternatively* you can use Phoenix/WinNonlin, STATISTICA, SPSS, Stata, JPM, or the -pack­age replicateBE.

» why using partially replicate design is not favorable nowadays? 

As a starter see this post and that one. I suggest also to search the forum with the keywords lousy and design. Most important reasons:

• FDA model
  If s_wR <0.294 you are not allowed to employ reference-scaling. The model for ABE might not converge in any software. Study done, no result. Bad luck.
  
• All models
  A three period full replicate design (TRT|RTR or TRR|RTT) is more informative than partial replicates because you can estimate the within-subject variance of T as well.

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• Schütz H, Tomashevskiy M, Labes D, Shitova A, González-de la Parra M, Fuglsang A. Reference Data­sets for Studies in a Replicate Design intended for Average Bioequivalence with Expanding Limits. AAPS J. 2020; 22(2):44. doi:10.1208/s12248-020-0427-6.
  Electronic Supplementary Material:
  Software codes, datasets, -script for installation qualification of replicateBE.

—
Dif-tor heh smusma 🖖
Helmut Schütz


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Complete thread:

• Sequence assignments in partially replicate design Loky do 2020-07-19 01:33 [Design Issues] 
  • Sequence codes irrelevant Helmut 2020-07-19 11:17
    • Sequence codes irrelevant Loky do 2020-07-20 00:10
      • 3-period full replicatesHelmut 2020-07-20 10:04
        • 3-period full replicates Loky do 2020-07-22 10:17