PharmPK Discussion - Two submissions with one study

• On 6 Nov 2007 at 10:15:15, mohammed muhiyideen (mmuhiyideen.at.yahoo.com) sent the message
  

  
  Dear all,
  
  Is it possible to submit a bioequivalence report of one study to both
  USFDA and EU by conducting a three way cross over with the test and
  two references(one from US and one from Europe)
  
  The result obtained from test and US reference(RLD) will be submitted
  to USFDA and the one obtained from test and EU reference will be
  submitted to Europe.Is it possible?
  expecting your valuable inputs,
  Muhiyideen
  
  

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• On 6 Nov 2007 at 10:15:15, mohammed muhiyideen (mmuhiyideen.-at-.yahoo.com) sent the message
  

  
  Dear all,
  
  Is it possible to submit a bioequivalence report of one study to both
  USFDA and EU by conducting a three way cross over with the test and
  two references(one from US and one from Europe)
  
  The result obtained from test and US reference(RLD) will be submitted
  to USFDA and the one obtained from test and EU reference will be
  submitted to Europe.Is it possible?
  expecting your valuable inputs,
  Muhiyideen
  
  

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• On 7 Nov 2007 at 09:44:18, "Manoj Kumar Paruthi" (Paruthim.at.hikma.com) sent the message
  

  
  That should not be a problem provided that the protocols are prepared
  clearly mentioning how you would like to treat the data and report.
  
  Regards/ Manoj
  
  Manoj K. Paruthi, Ph.D
  Sr. Manager, R&D
  
  

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• On 8 Nov 2007 at 10:05:45, Anuj_Saini.-at-.jubl.com sent the message
  

  
  The following message was posted to: PharmPK
  I am agree with your opinion.
  
  Would it be advisable to make one report or two separate reports? Does
  both the regulatroy authorities accept this kind of design of study?
  
  With Regards
  Anuj Saini
  
  

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• On 8 Nov 2007 at 08:32:15, "Manoj Kumar Paruthi" (Paruthim.-at-.hikma.com) sent the message
  

  
  Dear Anuj,
  
  No! It would be better to have a clear mention in the protocol that
  the 2 RLDs would be treated against the same test and 2 reports will
  be prepared. In this case even if test fails against one of the RLDs,
  you will be able to still submit the study that has passed.
  
  If you choose to prepare 1 report then test failing against any of the
  2 RLDs will make the situation complicated and it would be very hard
  to convince and push through such a study report to any regulatory
  agency.
  
  Any further comments!!!
  
  Regards
  
  Manoj K. Paruthi, Ph.D
  Sr. Manager, R&D
  Hikma Pharmaceuticals Plc.
  
  

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• On 9 Nov 2007 at 16:38:07, "Hiren Mehta" (hirenpharm.-at-.gmail.com) sent the message
  

  
  Dear members,
  
  As far as three way cross-over study is concern, three period is not
  acceptable by regulatory.
  
  Need to go for six period study and that is more complicated.
  
  Better to go for two different study.
  
  

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• On 9 Nov 2007 at 11:49:50, "Lavigne, Jean" (Jean.Lavigne.-at-.mdsinc.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Hiren,
  
  You wrote
  
  "As far as three way cross-over study is concern, three period is not
  acceptable by regulatory."
  
  For which regulatory is it not acceptable?
  Is there any reference, guidance or documentation for this?
  
  Thanks,
  
  Jean
  
  

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