PharmPK Discussion - Flutamide BE study for ANVISA - Analyte to be measured

• On 7 Oct 2013 at 12:45:57, narasimha reddy (r.nara.simha.reddy123.aaa.gmail.com) sent the message
  

  
  Dear all,
  
  We are planning to do BE study for Flutamide for an Brazilian company.
  What is the analyte to be measured for Flutamide BE study for ANVISA, Parent or metabolite or Both.?
  
  Thanks
  Narasimha Reddy
  
  

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• On 7 Oct 2013 at 23:23:39, Manisha (manishab.aaa.anazeal.com) sent the message
  

  
  Hi!,
  Flutamide and Hydroxyflutamide should be measured in plasma. Bioequivalence should be based on 90%
  CI of both Flutamide and hydroxyflutamide. Preference to be given to the parent molecule for
  determining bioequivalence and measurement of metabolite for   supportive evidence. In case you are
  unable to measure parent drug then bioequivalence can be based on the metabolite concentration.
  
  Manisha
  
  

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• On 8 Oct 2013 at 16:19:42, rmsampaio2002.at.yahoo.com.br (rmsampaio2002.at.yahoo.com.br) sent the message
  

  
  Dear Narasimha, according list number 02, guidelines described in ANVISA website, the analyte to
  mensure in this study of flutamide ( = flutamida) is just the metabolite hydroxyflutamide (=
  2-hidroxiflutamida).
  Plase, check out this information in direct link:
  
  http://portal.anvisa.gov.br/wps/wcm/connect/63981a80410f6e17993c9b9cca79f4cf/Lista_2_11_09_13.pdf?
  MOD=AJPERES
  
  Best regards.
  
  

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