PharmPK Discussion - Releasing BLQ datapoints

• On 17 Sep 2015 at 10:48:14, Chris Kemper (chris_kemper.aaa.PHARMANAVIGATORSLLC.COM) sent the message
  

  	
  To all:
  
  Last year at this time, there was an exciting exchange at PHARMPK on this topic. So much so that the
  Bioanalytical Focus Group of AAPS decided to incorporate a roundtable on "The Case For and Against
  the Release of Bioanalytical Data Below the LLOQ" at the AAPS Annual Meeting on October 28. Details
  can be found at https://annual.aapsmeeting.org/event/member/181195.
  
  So, if you are going to the AAPS meeting, try to attend the roundtable. Even if you can't,  I would
  appreciate hearing any comments or potential issues you think would be pertinent to this issue.
  
  Christopher J. Kemper, Ph.D.
  Pharma Navigators, LLC
  cell: 609-213-3038
  fax: 609-844-0312
  PK/PD/Bioanalytical Consulting
  Alliance Management/Business Analysis
  http://www.pharmanavigatorsllc.com/
  
  

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• On 17 Sep 2015 at 09:52:24, Edward O'Connor (efoconnor.-a-.gmail.com) sent the message
  

  	
  How about this.  The bioanalytical lab releases concentrations from and including the LLOQ to and
  including the ULOQ.  Response below the LLOQ are reported as another or the same table as the concentration, the Ba lab alos lists responses for all samples.
  The PK/PD people can take the response and do their own calculations.
  
  

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• On 17 Sep 2015 at 15:36:38, Dr. Prasad Tata (drprasadtata.-a-.yahoo.com) sent the message
  

  
  Chris:
  Is it not a case of splitting the hair?  These topics are good enough for academic discussion but in
  a regulated field like ours anything below LLOQ is "non reportable"  Fundemental principle in any
  analysis LLOQ meant to say below whatever the value below LLOQ is that it can not be measured with
  scientific and statistical confidence.  If folks are so obsessed with what is below LLOQ they better
  refine the analytical method and validate to a much more sensitive limits.   By challenging LLOQ I
  wonder how much mileage in accuracy these folks get in overall pharmacokinetics?
  
  Prasad NV Tata, Ph.D., FCP
  
  

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• On 17 Sep 2015 at 19:00:25, Chris Kemper (chris_kemper.-at-.pharmanavigatorsllc.com) sent the message
  

  	
  Hey Prasad:
  
  I couldn't have said it any better. But this has become a divisive issue unlike anything since ISR.
  
  Take care,
  Chris
  
  Christopher J. Kemper, Ph.D.
  Pharma Navigators, LLC
  
  [Interestingly in an academic setting the same lab is commonly doing the 'chemical' analysis AND the
  'pharmacokinetic analysis' so this question isn't always one side versus the other.
  
  

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• On 17 Sep 2015 at 20:27:10, Dr. Prasad Tata (drprasadtata.at.yahoo.com) sent the message
  

  
  Chris:
  
  the problem about these values below LLOQ is “Don't let the noise of others' opinions drown out your
  own inner voice."
  
  Regards,
  
  Prasad NV Tata, Ph.D., FCP
  
  

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• On 17 Sep 2015 at 20:27:59, Edward O'Connor (efoconnor.-at-.gmail.com) sent the message
  

  
  In a regulated lab the analysts cannot project beyond assay limits.  Therefore the LLOQ restraint
  and not reporting out any concentration below that.  We could report instrument responses for all
  samples including those below the LLOQ and let the PK people play. As long as the bioanalytical
  report does not report concentrations below LLOQ they are clear.  The PK folks will need to explain
  the manipulation so they do beyond that.
  
  

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