PharmPK Discussion - Sampling time point of an anticancer agent

• On 25 Aug 2013 at 21:27:02, Md Tarique Imam (tarique.62.aaa.GMAIL.COM) sent the message
  

  
  Hi all,
  
  I would like to know your valuable opinion and guidance on the following study.
  
  I am working on novel oral delivery of an anticancer agent (having pharmacokinetic similarity with
  Doxorubicin) using loaded NPs. This is a preclinical study.
  
  This anticancer agent is available for i.v. administration. It shows triphasic decline in plasma
  drug concentration.
  
  Kindly suggest me
  
  1.  Which Tmax to consider if it follows shows triphasic decline in plasma drug concentration (i.e.
  maximum concentration of drug in plasma or Avg Tmax)?
  
  2.   How to determine sampling time point (considering which parameters)?
  
  3. Which PK model to be used?
  
  Kind Regards
  Md Tarique Imam
  Ph.D. (Pharmaceutical Medicine)
  
  

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• On 7 Sep 2013 at 08:20:11, Md Tarique Imam (tarique.62.at.gmail.com) sent the message
  

  
  Hi all,
  
  In continuation of previous request, this is a kind reminder that I am working on a novel oral
  delivery of an anticancer agent (having pharmacokinetic similarity with Doxorubicin) using loaded
  NPs. This is a preclinical study.
  This anticancer agent is available for i.v. administration. It shows triphasic decline in plasma
  drug concentration.
  
  I need your valuable opinion for the consideration of dose for pharmacokinetic studies in rat. The
  human dose is 100 mg/m2  for i.v. use. Which methods can be used for oral dose determination in
  rats? What would be the oral dose in rats?
  
  Best Regards
  --
  Md Tarique Imam
  Ph.D. (Pharmaceutical Medicine)
  
  

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• On 7 Sep 2013 at 08:48:04, Michael Burnet (michael.burnet.aaa.synovo.com) sent the message
  

  
  Dear Tarique,
  There are too many variables to give you a really useful answer.
  A quick rule of thumb might be Rat doses ca. 3-4x human, oral doses 5 x i.v.
  Given that you are working with NPs, I would not expect very much from
  oral application unless they are very resilient NPs.   Only careful
  experimentation can help you there.   Bear in mind that some organs may
  take up your NPs rather avidly.
  Perhaps surprisingly, the i.p. route works well with larger forms, even
  NPs.
  Regards
  Michael
  --
  Michael Burnet
  Managing Director
  Synovo GmbH
  Paul Ehrlich Str. 15
  72076 Tübingen
  Germany
  
  

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