PharmPK Discussion - BE Food effect

• On 8 Mar 2007 at 07:09:02, Minal Deokar (deo_kar17.aaa.yahoo.co.in) sent the message
  

  
  Dear All,
  Can any one guide on the need of Bioequivalence study under fed
  condition for ANDA or European submission,
  if product monograph states that
  1. The bioavailability of product is not affected by food. Or
  2. It should be administered without regards of food. Or
  3. It can be administered with or without food.
  
  

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• On 9 Mar 2007 at 17:46:38, "KHALIL I M AL-KHAMISPh.D" (alkhamis.-at-.ksu.edu.sa) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Minal Deokar, Hi
  
  If your criteria as you stated you do not need to do Bioequivalence
  study under fed condition for ANDA or European submission. For more
  information consult PEMA  site.Good luck.
  Professor Khalil I M Al-Khamis, Ph.D
  
  

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• On 31 Mar 2007 at 08:54:50, "Prakash Patel" (Prakash.Patel.-at-.veedacr.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Dear Khalil,
  
  Could you please provide full address of PEMA site, I tried but I found
  some other website not related with BE study.
  
  Hope your cooperation in this regard,
  
  Thanks with Regards,
  
  Prakash Patel
  
  

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• On 31 Mar 2007 at 20:56:56, "KHALIL I M AL-KHAMISPh.D" (alkhamis.at.ksu.edu.sa) sent the message
  

  
  Dear Prakash Patell, Look to the following sites. Hoping to find what
  you wants. Good luck and best Regards,
  
  http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf
  
  

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