PharmPK Discussion - GMP Requirement for an Oral 14-C ADME Study in Man

• On 22 Jun 2012 at 08:15:26, David Benziger (David.Benziger.aaa.cubist.com) sent the message
  

  
  We have some non-GMP 14-C drug that was used for pre clinical studies.  If there
  is some degradation of this material (54 mCI/mmol) can we purify and mix a small
  amount of labeled drug with a large amount of GMP cold drug under GMP conditions
  and use in our human ADME studies.
  
  (Probably 50 uCi  in 250 mg total drug administered to man)
  
  Dave
  

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• On 22 Jun 2012 at 12:04:18, (Ttarnowski1.at.aol.com) sent the message
  

  
  David-
  Regarding "We have some non-GMP 14-C drug that was used for pre clinical
  studies.  If there
  is some degradation of this material (54 mCI/mmol) can we purify and mix a small
  amount of labeled drug with a large amount of GMP cold drug under GMP conditions
  and use in our human ADME studies.
  (Probably 50 uCi  in 250 mg total drug administered to man)," you can probably
  do this, as long as you comply with GMP, GCP, and ethical requirements.  It
  would be best to work with a CRO (e.g., Covance, Quotient, others) that does
  this regularly.
  
  -Tom
  
  Thomas L. Tarnowski, Ph.D.
  Corporate Liaison & Special Tasks Director
  Organizing Committee
  CACO Pharmaceutical and BioScience Society
  ttarnowski1.at.aol.com
  

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• On 22 Jun 2012 at 13:09:29, Frank Bales (frankbales.at.msn.com) sent the message
  

  
  David,
  
  All material for human use must be GMP.
  
  Frank Bales, Ph.D.
  
  

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Copyright 1995-2011 David W. A. Bourne (david@boomer.org)