PharmPK Discussion - Unavailability of same reference batch - repeat BE study

• On 19 May 2007 at 15:00:02, "Chanukya Priyadarshi" (access2clinicalresearch.-a-.gmail.com) sent the message
  

  
  Dear Group,
  Greetings for all,
  If we conduct BE studies (both fasting and fed) using a batch no:
  XXXX of reference products. Only fed study is meeting the BE
  criteria. To repeat (fasting) biostudy,  If we don't have sufficient
  number of same batch number of reference products, what could be the
  possible solution?
  Experts' opinion on the above critical situation would be appreciated.
  
  Thanks & Regards,
  Chanukya.
  
  

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• On 20 May 2007 at 11:26:07, Anuj_Saini.aaa.jubl.com sent the message
  

  
  The following message was posted to: PharmPK
  Dear Chanukya,
  
  As per my opinion should be repeat study done on the same batch. But
  in this scenario would you reveal in front of FDA that first fasting
  study failed and and without reformulating the test product second
  study passes. If second study passes FDA may suspect.
  In case of unavailability of innovator same batch you may write to
  FDA and get recommendation for the same. But I would like to open
  debate on my point.
  Regards
  Anuj Saini
  
  

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• On 22 May 2007 at 11:21:01, Pankaj Gupta (pankaj.-a-.invagen.com) sent the message
  

  
  You may not use the different brand lot in between fasting and fed
  studies. But definitely you can repeat the study with more no. of
  voulnteers if it was concluded it was not a formulation issue but
  failed due to high intra subject variation.
  Pankaj Gupta
  
  

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• On 23 May 2007 at 16:07:01, "sukhbir singh" (sukhbir83.at.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Chanukye,
  
  As per your query, if your study is at the exhibit level then change
  in the Batch of reference will not matter much as you might not be
  submitting the data to any body, you can have the data for support
  purpose. But if you are at the level of filling an ANDA or any other
  filling, then in my opinion you might have taken the reference which is
  already marketed and approved by the regulatory body, so the
  analytical data of two different batches can be submitted to the
  regulatory body as these should be identical.
  
  Regards
  Sukhbir
  
  

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