PharmPK Discussion - Bioequivalence of itraconazole

• On 30 Jul 2009 at 09:56:35, Shankar Swaminathan (bourne5321.at.gmail.com) sent the message
  

  
  Dear all,
  
  Can anyone please guide me regarding the bioequivalence guidelines
  regarding itraconazole formulation. I understand it is a molecule with
  very high intra and intersubject variability. Can anyone please throw
  some light on the calculation method of volunteer number for the study
  and the analytes to be quantified. Any specific regulatory reference
  would be highly and deeply appreciated and acknowledged.
  Regards
  
  SHANKAR SWAMINATHAN
  SENIOR RESEARCH FELLOW,
  A-257, C/o Prof. P. R. Vavia,
  UICT, N. P. Marg, Matunga, MUMBAI 400019
  
  

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• On 31 Jul 2009 at 12:42:31, bourne5321.aaa.gmail.com sent the message
  

  
  The following message was posted to: PharmPK
  
  HI Shankar,
  
  What I feel is last time when we worked on Itraconazole the product was
  not difficult to achieve bioequivalence.
  
  Though it is well known that it has high variability but with food
  variability goes down. I do remember a sample size of 40 subjects for
  Itraconazole may suffice the requirement of bioequivalence, but I am not
  confident about it.
  
  Please refer to the link below for some information on analysis of
  Itraconazole.
  
  http://www.boomer.org/pkin/PK00/PK2000122.html
  
  Bye
  
  

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• On 1 Aug 2009 at 10:30:33, "V.G.S.Raghavendra Mamidi" (bourne5321.at.gmail.com) sent the message
  

  
  Dear Shankar,
  
  The following link has been taken from the USFDA site for reference.
  
  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086271.pdf
  
  May be it helps for you. To find the sample size you need the
  parameters intrasubject CV and T/R Ratio.
  Thank you,
  --
  Regards,
  M.V.G.S.Raghavendra
  Biostatistician
  
  

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• On 3 Aug 2009 at 08:47:32, Devang Shah (bourne5321.at.gmail.com) sent the message
  

  
  Dear Shankar,
  
  Itraconazole produces a metabolite hydroxy-itraconazole. For a
  regulatory BE study, you will have to estimate the metabolite
  concentration also since it is active in nature. Literature also says
  that plasma conc of itraconazole diminishes rapidly. So method will
  have to be sensitive  enough.
  
  regards,
  
  Devang P. Shah.
  Senior Research Fellow (PhD Tech Fellow),
  Dept of Pharmaceutical Sciences and Technology,
  Pharmacology Lab II,
  Institute of Chemical Technology,
  N. P. Marg,
  Matunga, Mumbai 400 019.
  
  

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