PharmPK Discussion - Assay revalidation

• On 5 Oct 2007 at 15:26:18, "priyadeep.bhutani" (priyadeep.bhutani.at.advinus.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear All
  
  Suppose I have done full validation of any drug in rat plasma, now I
  need to do partial validation in dog plasma.
  I HAVE A QUESTION :
    Do I need to do dilution integrity in dog plasma also, what fda
  accepts
  
  I would appreciate if I can get references for the same
  
  Thanks in advance
  
  Priyadeep bhutani
  
  

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• On 20 Jul 2007 at 11:17:34, "Ed O'Connor" (eoconnor.-a-.matrixbioanalytical.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  1) How much risk are you willing to assume?
     A) Is the recovery the same?
     B) Are the interferences the same (See E, below)
     C) Is the stability the same?
     D) Is the dilutional linearity the same?
     E) Is the LLOQ the same?
  
  2) If you are willing to assume a great deal of risk, a partial
  validation would seem to save money and time.   Be advised though, that
  you may encounter some difficulty which will cost you time and money
  later.  Some of the difficulty would be in answering why you chose to
  make the assumptions you did a priori.
  
  3) It is better to run a full validation of the second species rather
  than run the risk of failing one or more!
  
  --
  Ed O'Connor, Ph.D.
  Laboratory Director
  Matrix BioAnalytical Laboratories
  25 Science Park at Yale
  New Haven, CT  06511
  Web:     www.matrixbioanalytical.com
  Email:    eoconnor.aaa.matrixbioanalytical.com
  
  

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• On 5 Oct 2007 at 17:21:54, gilles-jacques.riviere.at.novartis.com sent the message
  

  
  Dear Priyadeep,
  
  In this case, I usually validate the dilution for every species tested.
  Best regards,
  
  gilles
  
  

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• On 5 Oct 2007 at 15:31:30, ogwal sidney (sidneyogwal.-a-.hotmail.com) sent the message
  

  
  There is no room for partial revalidation where you do any validation
  or revalidation it should be Complete
  Particularly where you want ultimately the results to be published.
  However in a situation where you are doing research not for serious
  purposes it is okay.
  
  s.o.o
  
  

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• On 6 Oct 2007 at 00:34:06, Ttarnowski1.at.aol.com sent the message
  

  
  Dear Priyadeep,
  I offer my comments regarding the question of partial validation or
  full validation for a second species (or in other words, what level
  of validation to perform with the second species?).
  
  Unless you have extensive experience with the analyte in the two
  species and can be very sure that the performance and range will be
  the same, I would recommend full validation.  However, stability of
  the stock solutions need not be retested if the same concentration is
  used.
  
  I have seen many cases in which an assay in dog plasma performed
  differently from the one in rat plasma.  Better to determine this up
  front than to run an abbreviated validation and find that there are
  assay problems when you analyze study samples.
  
  After you perform 2 animal species and a human validation and find
  all to be similar and predictable, I would be willing to consider a
  partial validation for the next species (same matrix).
  
  -Tom
  
  Thomas L. Tarnowski, Ph.D.
  Bioanalytical Development
  Elan Pharmaceuticals, Inc.
  800 Gateway Boulevard
  South San Francisco, CA 94080
  thomas.tarnowski.at.elan.com
  
  

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