PharmPK Discussion - Reproducible in vivo PK studies

• On 17 Jul 2015 at 18:53:38, binzhu101.aaa.gmail.com sent the message
  

  
  I am new in the PK CRO business. Recently my reports dealt with a client who wanted us to repeat a
  rat PK study to demonstrate that our in vivo PK studies are reproducible.
  
  In my old days at Big Pharm, animal PK studies with sample size of 3 were commonly practiced. When a
  PK study ended up with big variations, we repeated the study. With acceptable variations, we moved
  on. We did not have to address the issue of reproducibility for obvious reason, i.e., sample size of
  3!
  
  Sitting at another side of table now, I think that I will probably face this issue often and would
  like to give reasonable answers. But, what to expect? Comments, suggestions, practical experience
  and examples are highly appreciated.
  
  Best Regards,
  
  Bin
  
  

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• On 17 Jul 2015 at 23:06:23, Tausif (mailtaus.-a-.yahoo.com) sent the message
  

  
  Hi Bin,
  Variability in animal PK is pretty common. We would consider a 30% variability pretty acceptable.
  One way to reduce is to select animals of very similar weights. Otherway is to use serial sampling,
  use n=6 n use cannulated rats. Even in Bioanalytical 15% variability is acceptable. Thus Inter
  animal Variability is unavoidable.  Hope it helps.
  Thanks
  
  Tausif Ahmed PhD
  Director,  Bioanalytical,
  Dr. Reddys Laboratories, Hyderabad, India
  
  

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