FDA RSABE Project template_ v1.4.phxproj [🇷 for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2020-07-19 03:45 (926 d 05:36 ago) – Posting: # 21747
Views: 13,980

Hi mittyri,

❝ are you referring to that template for RSABE?


Nope. I was using “FDA RSABE Project template_ v1.4.phxproj” of 2014-11-11 (should be accessible at https://www.certarauniversity.com/store/637337-106-fl-free-phoenix-templates-for-bioequivalence-regulatory-guidances but my credentials were not accepted (why the heck?) and when I tried to reset the password I didn’t receive the confirmation e-mail…).
Relevant part:

FDA RSABE Project template_ v1.4
 ↳ Workflow
  ↳ RSABE
    ↳ Prepare Data for RSABE analysis
      ↳ Intermediate ilat (Dependent: ilat, Fixed Effect: Sequence)
          Result: Final Variance Parameters
            Estimate
            ↳ Transformation Type = Arithmetic
              Transformation = x / n
              New Column Name = Var_wr
              n = 2
              Var_wr
              ↳ Transformation Type = Functions
                Transformation = Square root(x)
                New Column Name = sWR


The main difference to v1.3 is that v1.4 uses the function chiinv(0.95,df) further down which was not available in PHX6.3 and a table of values had to be used instead.
However, with v1.3 you get the same result like in this post.


PS: Ref.35 of doi:10.1208/s12248-020-0427-6 leads to limbo. Not very professional. I asked Certara’s support to establish a permanent redirect on the server.

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