PharmPK Discussion - Acceptance Criteria for Analytical Batch

• On 12 Apr 2011 at 16:16:20, Hamid Shaikh (hamid.shaikh.-at-.ashco.in) sent the message
  

  
  What are the acceptance criteria for subject sample analysis batch?
   If the subject samples are processed in batch wise manner then there  will be processing batch acceptance criteria (Using 48 station Solid  phase Extraction Unit, there will 2 Processing batches in the analysis  of 96 sample acquisition batch).
  For e.g. the batch organization is as follows:
   Calibration Curve
  QC Set -1
  Subject samples P-I
  QC Set-2
  QC Set-3
  Subject Sample P-II
  QC Set -4
   So please clarify the acceptance criteria for processing batch as well  as whole batch.
   Thanks with Regards
  Hamid Shaikh
  
  

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• On 13 Apr 2011 at 15:40:30, "Edward O'Connor" (efoconnor.at.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  1'd Suggest run curve at beginning and end apply your valdiation
  criteria to batch acceptance 1) CV <20?, BIas <|20|?,  how many points
  must pass?  what is the LLOQ and ULoq acceptance-they must pass.  run
  QC throughut the batch not confined to one section.   If you run three
  QC in each set what is you acceptance> CV and BIAS,  usually you can
  reject a number of QCs (1/3) so long as you do not lose an entire
  level.  With 4 sets I suppose you could indicate that you could lose 1/4
  so long as they are not at the same level.
  
  

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• On 31 May 2011 at 16:17:45, Jack Wang (wxinting1986.aaa.gmail.com) sent the message
  

  
  I think the QC samples should be dispersed in the whole analytical  batch. In my laboratory, we usually would require the QC samples be no  less than 5% of the analytical samples. However, sometimes there would  be less than 100 samples, such as 72 samples. If you just put 3 to 4 QC  samples that would not be able to verify your sample processing process.  So we usually put 9 samples with at least 3 samples for each  concentration.
  
  Deviation between the each QC sample and the theoretical concentration  should not exceed 15%.
  -- Yours, Xinting Wang
  Email: wxinting1986.at.gmail.com
  Key Laboratory of Drug Metabolism & Pharmacokinetics
  China Pharmaceutical University
  24, Tongjia Xiang Road
  Nanjing, Jiangsu
  People's Republic of China, 210009
  
  

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