PharmPK Discussion - ISR for an AMS method

• On 5 Jan 2012 at 16:29:52, Joi Dunbar (Joi.Dunbar.aaa.infi.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Hello-
  
  Can anyone provide their experience of conducting an ISR for a study
  which utilizes AMS as an analytical technique?  I don't expect the AMS
  method to be used in additional studies, but do anticipate that results
  from the study would be submitted as part of a regulatory package.  I
  realize the options range from following the current recommended ISR
  guidelines to do nothing at all; I am trying to get a sense of "real
  world" experience and what the regulatory expectations are for an
  analytical method with limited applicability.
  
  Thank you in advance,
  
  Joi Dunbar
  Infinity Pharmaceuticals, Inc.
  
  

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• On 8 Jan 2012 at 10:14:34, "Edward O'Connor" (efoconnor.-at-.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Which AMS- accelerator MS or aerosol MS?
  But that is irrelevant!   See
  http://www.aapsj.org/view.asp?art=aapsj0903040
  this gives a pretty
  expansive treatment.  Another approach is to simply calculate the
  difference of the two measure and express this as a ratio or percent
  of the mean of the two measures.   For instrumental techniques the
  %generated should be 20 to 25% and 25 to 30 % for ligand based.  As a
  rule slightly larger than the accuracy  and precision of the
  analytical method.
  
  --
  Edward F. O'Connor
  efoconnor.-a-.cox.net
  efoconnor.at.gmail.com
  www.aegisbioconsult.com
  
  

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