PharmPK Discussion - Post study safety sample

• On 21 May 2012 at 10:32:51, (pravindeotarse.aaa.lupinpharma.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear
   In BA/BE studies when should the post study safety sample taken if subject is
  withdrawn before end of study. shall we take at the same time of withdrawl or as
  per schedule procedured i.e at the end of study.
  
  Pravin Deotarse
  Lupin.
  
  

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• On 22 May 2012 at 01:15:48, Sanjay Kumar (sanjay192.aaa.gmail.com) sent the message
  

  
  Dear Pravin,
  
  If subject has been withdrawn from the study due to AE/SAE post study samples
  should be taken at the time of withdrawal if practically possible otherwise
  after resolving AE/SAE.
  
  In case the reason for subject withdrawal is noncompliance or any other reason
  the sample can be taken as per schedule.
  
  Regards,
  Sanjay Kumar
  Panvel, Mumbai
  

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• On 22 May 2012 at 21:20:03, drgunasakaran (drgunasakaran.-at-.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Mr Pravin Deotarse,
  
  The timing of collection of Post study sample in a Bioequivalence study
  depends on the reasons for which the subject is withdrawn from the study.
  
  Reason 1: Subject is withdrawn from the study due to medical reasons
  In the above scenario, it is ideal to take post study sample collection
  after the complete resolution of the adverse event to check the laboratory
  parameters returns to normal after the resolution of AE.
  
  Reason 2: Subject is withdrawn from the study due to personal reasons, not
  due to any medical reasons
  In the above scenario, we need to take the post study sample only at the end
  of study period as scheduled in the protocol. If the subject is not willing
  to come for post study evaluation at the end of last period, the same
  unwillingness to give post study sample should be recorded in the Post study
  collection record and should be documented. Collecting post study sample
  immediately is accepted in some rare circumstances only.
  
  Regards,
  Dr S Gunasakaran, MD
  Head - Clinical Research & Medical Affairs,
  Azidus, Clinical Research Organization, Chennai, India.
  www.azidus.com
  
  

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