PharmPK Discussion - Clarifications regarding redosing study

• On 10 Mar 2007 at 12:52:15, "V.G.S.Raghavendra Mamidi" (mamidi.ganesh.aaa.gmail.com) sent the message
  

  
  Dear all,
  We have recently done a regulatory (US) study where only one subject
  is behaving in a anomalous manner, effecting the study outcome. The
  sponsor after communication with USFDA has asked us to conduct a
  'mini' redosing study with the same subject and 5 other subjects from
  the same study (Totally 06 subjects who completed the same study).
  The objective is that if in the current study the subject behaves
  differently, then they would have justification to remove him from
  the statistical analysis of the original study report. We are not
  clear on what are the criteria by which this subject data will be
  compared with the other 6 subjects and what is the criteria for
  deciding whether he is normal OR anomalous. How are they going to
  proceed with the PK analyis? Is it possible to use this new data of
  that only one subject along with the old data of other subjects and
  perform a PK analysis?
  Can you provide any insight into this issue? The procedure to perform
  PK analysis if such situation occurs?
  If there are any websites or guidelines regarding the add-on
  (redosing) studies, kindly let us know.
  --
  Regards,
  Raghavendra
  
  

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• On 10 Mar 2007 at 11:24:27, "Ed O'Connor" (Ed.OConnor.aaa.tandemlabs.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  What is the nature of the drug?  Protein/peptide or small molecule.
  Please give add detail
  
  Ed O'Connor, PhD
  Technical Director, Immunoanalytical
  Tandem Laboratories
  115 Silvia Street
  West Trenton, New Jersey
  609-228-0243
  
  

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• On 13 Mar 2007 at 09:46:40, "Sitec Labs" (clinical.at.siteclabs.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Ed O'Connor,
  If it is a small molecule what should be the criteria?
  
  Thanks
  
  

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• On 13 Mar 2007 at 11:12:54, "V.G.S.Raghavendra Mamidi" (mamidi.ganesh.aaa.gmail.com) sent the message
  

  
  Dear Ed O'Connor ,
  It is a combination of two drugs (desloratidine + pseudoephedrine) so
  pls clarify.
  Thanks and regards,
  Raghavendra
  
  

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• On 13 Mar 2007 at 07:55:00, "Ed O'Connor" (Ed.OConnor.at.tandemlabs.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  you may have run in to a donor more sensitive to the physiological
  effects of these drugs on smooth muscle, and these effects will impact
  the distribution, metabolism and clearance.  Did the donor report any
  sensations other than what was reported for the other donors?
  
  Ed O'Connor, PhD
  Technical Director, Immunoanalytical
  Tandem Laboratories
  115 Silvia Street
  West Trenton, New Jersey
  609-228-0243
  
  

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