PharmPK Discussion - BE study for artemether and lumefantrine

• On 10 Dec 2012 at 20:36:57, narasimha reddy (r.nara.simha.reddy123.aaa.gmail.com) sent the message
  

  
  Hi,
  
  We are planning to do bioequivalence study of artemether and
  lumefantrine for WHO submission.
  Which study we need to do.? Fasting or Fed?
  Whether we need to analyse Dihydroartemisinin for WHO submission?
  
  Narasimha Reddy
  
  

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• On 10 Dec 2012 at 12:19:37, John Gordon (jdgordon.-a-.ns.sympatico.ca) sent the message
  

  
  The following message was posted to: PharmPK
  Narasimha,
  
  Your questions are answered on the WHO Prequalification Programme (PQP)
  website at
  
  http://apps.who.int/prequal/info_applicants/BE/Art-Lum_BE_2008April.pdf
  
  Also, the PQP will happily provide advice to those that are planning to
  submit applications to their programme. If you have any other questions
  regarding their requirements, I suggest you contact them directly...
  
  John
  
  

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• On 10 Dec 2012 at 23:43:07, DRGUNA SAKARAN (drgunasakaran.aaa.gmail.com) sent the message
  

  
  Dear Mr Narasimha Reddy,
  
  1. Which study we need to do.? Fasting or Fed?
  You need to conduct Fed study for artemether and lumefantrine meant for
  WHO submission.
  As it is recommended to take the originator tablets of artemether and
  lumefantrine with food, and the absorption is more variable if the
  tablets are taken in the fasted state, we recommend administration of
  the tablets with a standard breakfast, not a high-fat, high-calorie
  meal, as a standard breakfast is considered to be closest to real life
  conditions in malaria patients.
  
  2. Whether we need to analyse Dihydroartemisinin for WHO submission?
  The parent drug is considered to best reflect the rate and extent of
  absorption for artemether as well as for lumefantrine. The data for the
  parent compound(s) will be used to assess bioequivalence. Although the
  results of the parent compound will be used for the decision on
  bioequivalence, if data are available for the metabolite
  dihydroartemisinin, it is asked that pharmacokinetic and statistical
  results for this metabolite also be provided as it will help the WHO to
  understand the relationship between parent and metabolite, and will
  provide scientific knowledge in the area of decision-making.
  
  Reference: WHO Prequalification of Medicines Programme, Notes on the
  design of bioequivalence study: Artemether + Lumefantrine, Guidance
  document, April 2008.
  
  Regards,
  Dr.S.Gunasakaran, MD
  Head - Clinical Research & Medical Affairs,
  Azidus, Clinical Research Organization, India
  
  

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