PharmPK Discussion - Bioanalytical guidelines acceptance criteria

• On 4 Oct 2007 at 09:25:39, muthuswamy chinnaiah (muthuswamy_23.-at-.yahoo.co.in) sent the message
  

  
  Dear all,
  I have two questions regarding bioanalytical guidelines (FROM SHAH 2000)
  
  1- ''Usual acceptance criteria for QC are at least 67% of the QC samples
  within 15%''. Does anyone use additional criteria; as exemple if the
  last
  two QCs are low (-20 and -30%, respectively) showing a drift at the end
  of
  the run, the samples between these two QCs are re-assayed?
  
  2- ''Standard curve acceptance criteria are that 75%, or a minimum of 6
  standards should fall within 15%..''.Does that mean that a standard
  curve is accepted with (in any cases) at least 6 standards in the 15%
  range?
  
  Does that also mean that if more than 6 standards are analyzed, 75%
  should be
  accepted (with always a minimum of 6 in the 15 % range?) or does that
  mean that a standard curve containing 6 standards could be accepted
  if 75%
  (i.e.: 5 standards) are in the 15% range?
  
  REGARDS,
  MUTHUSWAMY.C
  HYDERABAD
  
  

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