PharmPK Discussion - SOP for assay procedure development

• On 2 Jan 2007 at 03:51:29, venky bayya (bvkanna55.-at-.yahoo.com) sent the message
  

  
  Do we need SOP for assay procedure development in bioanalysis. Please
  give me sugession
  
  B.Venkat
  Associate Research Scientist
  Aizant Drug Research Solutions
  e-mail:bvkanna55.-a-.yahoo.com
  
  

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• On 3 Jan 2007 at 04:08:38, mandar mote (mandarmote4.-at-.yahoo.co.in) sent the message
  

  
  Dear Venky,
  
  Yes it is necessary to have one as most of the regulatory agencies
  ask for the same. And now a days they inspect the method development
  data too before inspecting the validation and study data.
  
  Dr. Mandar Mote
  Head Bio-analytical
  CRO
  Cadila Pharmaceuticals Ltd.
  Ahmedabad.
  
  

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• On 4 Jan 2007 at 23:27:32, "Ed O'Connor" (Ed.OConnor.at.tandemlabs.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dick Norlin, now at Charles River put it succinctly.  A protocol
  describes  what you will do, the SOP describes how you will do it.   An
  SOP for development should not be specific and should be a flow chart/
  decision tree of items in development.  More specificity can be added in
  a protocol which would address developemnt for a specific compound in a
  specific matrix.   After Development you can also design an general SOP
  for validation, supported by a specific protocol for the compound and
  matrix.   Finally, the product of validation is a specific method or sop
  to be applied in sample analysis.
  
  Ed O'Connor, PhD
  Technical Director, Immunoanalytical
  Tandem Laboratories
  115 Silvia Street
  West Trenton, New Jersey
  609-228-0243
  
  

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