PharmPK Discussion - Bioequivalence of Drug Products for ANDA submission

• On 1 Mar 2007 at 03:34:20, Minal Deokar (deo_kar17.-at-.yahoo.co.in) sent the message
  

  
  Can we do Bioequivalence of Drug Products for ANDA submission whose
  strength is not RLD?
  For example, Bioequivalence of Drug Products for ANDA submission
  whose strength is 850 mg.
  But reference product 850 mg is not RLD with whom it will be compared.
  1000 mg is RLD.
  So can we do BE study though reference is not RLD?
  Awaiting for your expert comments.
  Thanks & Regards
  Minal Deokar
  
  

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• On 1 Mar 2007 at 10:32:26, "Manoj Kumar Paruthi" (Paruthim.aaa.hikma.com) sent the message
  

  
  Dear Minal,
  
  If you have any specific objective for conducting such a study, then you
  can go ahead, but successful qualification of the study may not help you
  to get bio waiver of other strengths be it higher and/ or lower.
  
  Regards
  Dr. Manoj K. Paruthi
  Sr. Manager, R&D
  
  

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