PharmPK Discussion - Comparative pharmacodynamics

• On 2 Jun 2009 at 16:32:11, Prasoon Mishra sent the message
  

  
  Dear Sir,
  
  As per FDA guideline for ANDA submission, Clinical trial studies are
  required against Innovator.
  
  Type of studies are mentioned as
  
  1) Comparative bioequivalence
  
  2) Comparative Pharmacodynamics
  
  3) Comparative clinical trial/ clinical endpoints
  
  4) Comparative In-vitro test
  
  I would like to know basic difference among Comparative clinical
  trial, comparative pharmacodynamics & comparative In-vitro test.
  
  Best regards
  
  Prasoon Mishra
  
  Sr. Executive - Business Development
  
  Corporate Office, New-Delhi (India)
  
  PROMED Exports Pvt. Ltd.
  
  www.promedgroup.com
  
  

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