PharmPK Discussion - Paracetamol CR BE study

• On 26 Nov 2007 at 15:26:55, "vasu polemera" (hellovasu1.-at-.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  Any body can clarify my doubt regarding Paracetamol Prolonged release
  tablets BE study.
  
  Is both fed and fasting study required for prolonged release tablets.
  As guideline says both required if food had impact on the
  bioavailability of the drug.
  
  In this case australian reference product mentioned no effect of the
  food on paracetamol. But literature says food had considerable effect
  on the bioavailability of the paracetamol. This information is for
  regulatory submission.
  
  P. VASU
  Medreich Limited
  Banglore
  
  

  Back to the Top

• On 27 Nov 2007 at 11:10:36, "gaurav shah" (swatantraa.at.gmail.com) sent the message
  

  
  The following message was posted to: PharmPK
  
  dear vasu ,
  
  as such every high fat calorie diet has effect on bioavailabilty of
  drug , the point is that is significant on ADME of drug at the
  specific time.
  
  as your Paracetamol formulation is prolonged released tablet so the A
  and D phase would be later as compare to normal tablet, so food would
  not have much impact (possibly) , so fed study might not be required,
  
  but as you need information for regulatory submission, if it is for US
  then you can refer OGD recommendation for particular product which can
  give clear light for this issue
  
  

  Back to the Top

Copyright 1995-2011 David W. A. Bourne (david@boomer.org)