PharmPK Discussion - Dose lost during BE study

• On 12 Jan 2007 at 20:33:11, "Vishal Patel" (vishal.aaa.lambda-cro.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear All,
  
  How to handle the data w.r.t to vomiting episodes of volunteer in
  typical BE studies with IR products as well as ER formulation.
  
  As per US FDA guidlines for IR formulation: Data of Subjects vomits
  within 2 times median Tmax may be excluded from the statistical
  analysis & same way for ER formulation Data of subjects vomits within
  label dosing interval may be excluded from data analysis.
  
  Has anybody experience handling such kind of issue w.r.t including
  such subject's data in the trial & acceptance of the data from US FDA
  perspective.
  
  Kindly advise.
  
  Vishal A. Patel
  
  

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• On 12 Jan 2007 at 11:52:18, "Kavanagh, Ronald E" (ronald.kavanagh.-at-.fda.hhs.gov) sent the message
  

  
  The following message was posted to: PharmPK
  
  I believe you are correct regarding the FDA guidelines. However it
  should be noted that for drugs that cause vomiting, especially when it's
  related to the rate of release (e.g. dopamine agonists), even though
  data from these subjects cannot be analyzed statistically or even if
  included will not indicate alter the statistical determination of
  bioequivalence. The very existence of or preponderance of vomiting in
  one group or another can indicate inequivalence and a safety concern.
  
  Ron Kavanagh, BS Pharm, PharmD, PhD.
  Senior Reviewer Clinical Pharmacology
  FDA
  
  

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