PharmPK Discussion - PK of Pegylated vs non pegylated IFN molecules

• On 11 Jan 2015 at 14:26:42, vishal pavitrakar (vpavitrakar.-at-.GMAIL.COM) sent the message
  

  
  Hello,
  
  I am studying bio equivalence of pegylated IFN alfa 2b molecules in healthy subjects. As it is a
  prodrug and most of desired effects is by its parent moiety IFN alfa 2b, after slowly release from
  Peg molecule, what do you suggest to measure PegIFN alfa 2b or simply IFN alfa 2b in healthy
  subject?
  
  best regards,
  VP
  
  

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• On 11 Jan 2015 at 10:33:38, Palakshi Gouda O (opalakshigouda.at.gmail.com) sent the message
  

  
  Dear Vishal,
  As it is PEGylated IFN, it is good to have both the data, which helps to correlate the plasma
  concentrations of free IFN with respect to PEG IFN available in total circulation  volume.
  
  Hope this helps.
  
  Best Regards
  Gouda
  
  

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• On 11 Jan 2015 at 10:34:57, Mark Milton (markmiltonpharmaceutical.-at-.gmail.com) sent the message
  

  
  Vishal,
  If you are looking at a biosimilar to PEGASYS, then measure the pegylated molecule.  PEGASYS is not
  a pro-drug.  It is stable in vivo and the pegylated compound is active.  There’s nothing about
  PEGASYS that would lead to it being considered a pro-drug.  If the molecule is a pegylated
  interferon that is designed to break down rapidly and release interferon, then you would need to
  measure both parent and metabolite.  However, I can’t see why anybody would want to develop such a
  molecule since it would be inferior to PEGASYS.
  
  Cheers
  
  Mark
  
  

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• On 12 Jan 2015 at 10:18:40, Ttarnowski1.aaa.aol.com sent the message
  

  
  This seems similar to Schering's (now Merck) Peg-Intron.
  
  -Tom
  
  Thomas Tarnowski
  Director, Bioanalytical Chemistry
  Gilead Sciences, Inc.
  
  

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