PharmPK Discussion - Scaled average bioequivalence

• On 29 Feb 2012 at 21:16:25, shikha rawat (shikha06rawat.aaa.gmail.com) sent the message
  

  
  Hi  all,
  
  This is the first time I am posting a mail on Pharm PK.
  
  I have some doubt regarding the SABE (scaled average bioequivalence) how
  can we find the confidence bound for the PK parameters of interest in
  this study. does winnonlin give this confidence bound? according to my
  knowledge it only provides us the PBE and IBE bounds (reference scaled
  as well as constant scaled). Looking forward to your reply.
  
  Thanks and kind regards
  
  shikha rawat
  
  

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• On 1 Mar 2012 at 14:26:39, Helmut Schuetz (helmut.schuetz.at.bebac.at) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Shikha!
  
  There is not native 'push-the-button' solution for SABE (like ABE and
  PBE/IBE) implemented - neither in (classical) WinNonlin nor in
  Phoenix/WinNonlin. I highly recommend to upgrade to Phoenix (free of
  charge with a current WinNonlin license) because renewal will end in
  June 2012 (v5.2.1) and September 2012 (v5.3).
  Theoretical it is possible to set up SABE in WinNonlin but this is a
  cumbersome and error-prone task, IMHO. In Phoenix it is much easier.
  Some hints here:
  http://forum.bebac.at/mix_entry.php?id=7871
  Essentially you have to setup the analysis according to SAS-code
  provided in FDA's progesterone guidance (Feb 2011). Unfortunately five
  lines of code are missing in the PDF. For the complete code see here:
  http://forum.bebac.at/mix_entry.php?id=7854
  To calculate the critical bound you need values of the inverse Chi-sq
  distribution, which are not available as a function in both WinNonlin
  and Phoenix.
  My workaround was to generate a table in R (http://cran.r-project.org/);
  code:
   options(digits=16)
   for (dfd in seq(1,200, by=1)){
     Cinv <- qchisq(0.95, df=dfd)
     cat(paste(dfd, "\t", Cinv, "\n"))
     }
  Save results in TXT- or CSV-format and import it into Phoenix.
  
  Native support of RSABE (FDA) and ABEL (EMA) is scheduled to be
  implemented in a future relase of Phoenix (QC_PHX6269), but will not be
  part of the next release (6.3) targeted for end of March this year.
  I have already setup a workflow in the Release Candidate 3 of v6.3beta
  and will publish a whitepaper once the final version is available, time
  allowing:
  http://bebac.at/Lectures.htm#WP
  
  Best regards,
  Helmut
  
  -
  Ing. Helmut Schuetz
  BEBAC - Consultancy Services for
  Bioequivalence and Bioavailability Studies
  Neubaugasse 36/11
  1070 Vienna, Austria
  web     http://bebac.at/
  forum   http://forum.bebac.at/
  
  

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