PharmPK Discussion - Smooth in bioanalysis

• On 17 Jan 2011 at 09:47:31, Devangi B Soni (devangisoni.-a-.lambda-cro.com) sent the message
  

  
  Dear Sudiptu and Rafel,
  
  Thanks for the information. But now a days, all sponsor are asking to  set the same integration parameters in the all analytical batches of  study, which were used in the method validation.
  
  So it is suggested to add, all integration parameters in the Method SOP  (molecule specific SOP) after completion of method validation and the  same will be( must be)  used for study.
  
  In the ANVISA guideline "Resolution - RE no 895, of May 29, 2003",  section No. 4.12.3.1, they have asked the integration parameters in the  SOP.
  
  Devangi Soni.
  
  

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