PharmPK Discussion - Bioequivalence based on metabolite only and not parent compound

• On 7 Mar 2012 at 18:06:31, narasimha reddy (r.nara.simha.reddy123.-a-.gmail.com) sent the message
  

  
  Dear all,
  
  As per FDA, for most of the molecules with metabolite estimation,
  Bioequivalence will be based on 90% CI for the parent compound and we
  need to submit the metabolite data as supportive evidence of comparable
  therapeutic outcome.
  
  Is there any molecule(s) in which the Bioequivalence will be based on
  only metabolite and supportive evidence need to be provided for the
  parent compound.
  
  Narasimha Reddy
  
  

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• On 7 Mar 2012 at 21:54:28, drgunasakaran (drgunasakaran.-at-.gmail.com) sent the message
  

  
  Dear Narasimha Reddy,
  
  As per FDA's Individual Product Bioequivalence Recommendation for
  Mifepristone,
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259169.pdf
  Bioequivalence will be based only on the primary
  metabolites of mifepristone, N-monodemethylated (RU 42 633) and
  hydroxylated (RU 42 698).
  
  FDA recommends to submit the data of the parent drug, mifepristone, only
  as supportive evidence of comparable therapeutic outcome.
  
  Reference: FDA's Individual Product Bioequivalence Recommendation
  Guidance for Mifepristone
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259169.pdf
  
  Regards,
  Dr.S.Gunasakaran, MD
  Head - Clinical Research & Medical Affairs,
  Azidus Clinical Research Organization, India
  

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• On 7 Mar 2012 at 16:42:23, "Ebes, Frieda" (Frieda.Ebes.aaa.INCResearch.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  My best guess is that for any compound that is a pro-drug which is
  metabolized into the active ingredient (one or more active metabolites),
  while the parent is not contributing to the pharmacologic activity, you
  would have to present metabolite data. But this is only my common sense
  (which could be very wrong of course!!)
  Frieda
  
  frieda.ebes.-a-.incresearch.com | www.incresearch.com | INC Research(r)
  
  

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• On 8 Mar 2012 at 09:22:35, Gilberto De Nucci (denucci.at.gilbertodenucci.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  It is common sense but the regulatory organs ask for the parent
  compound, since it would be more discriminative for evaluation of the
  dosage form.
  
  

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