PharmPK Discussion - SDTM PC and PP datasets from mass balance trials

• On 15 Mar 2015 at 22:57:17, Shoaf, Susan (Susan.Shoaf.aaa.otsuka-us.com) sent the message
  

  
  Hello All,
  Our company is trying to implement SDTM and CDISC standards.
  
  In the PKPARM code list for pharmacokinetic parameters, I can't find any codes for Cmax,u,
  AUCinfinity,u or AUCt,u.
  
  Does SDTM not allow for Unbound parameters to be reported?
  
  Also, is determination of the free fraction in Plasma/serum from a spiked sample considered a
  "non-clinical study with human biomaterials" result and therefore these data would not be submitted
  in a PC SDTM dataset? And why unbound PK parameters cannot be reported in the PP SDTM dataset as
  they represent values obtained by using a non-clinical value?
  
  Any insight would be appreciated.
  
  Thanks
  
  Susan
  
  Susan E. Shoaf, PhD
  OPDC
  Rockville, MD 20850
  
  

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• On 17 Mar 2015 at 13:31:44, Elizabeth Ludwig (Elizabeth.Ludwig.-at-.cognigencorp.com) sent the message
  

  
  Hello Susan,
  
  You raise some very relevant questions. The CDISC/NCI SDTM controlled terminology codelist for PK
  parameters is an extensible codelist, meaning that new terms may be added as long as the terms are
  not duplicates or synonyms of existing terms.
  
  In preparing datasets for various clients, we have found the information on this topic in the most
  recent version of the controlled terminology to be helpful
  (http://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM%20Terminology.xls).
  
  Kind regards,
  Beth
  
  

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