PharmPK Discussion - PK gender difference study

• On 24 Sep 2015 at 02:59:40, riswanto.tan.at.YAHOO.COM sent the message
  

  
  Dear all,
  
  When studying about phase I design, some questions emerged.
  
  When we are developing a fixed combination of two known drugs (of course with established PK data
  for each single entity), is there any possibility the gender difference might be different from each
  single drug?
  
  Example
  Drug A: no gender difference
  Drug B: plasma concentration is 2 times higher in female, but no difference in efficacy
  
  Drug (A+B): let say it is under development and no PK interaction is expected but no robust clinical
  evidence. Dose of each component is not higher than those already on market.
  
  So if one is making a new combination of A+B, is gender difference study need to be incorporated in
  Ph 1 PK study of new combination? From regulatory perspective, Is there any requirement regarding
  this issue from major authority like FDA or EMA?
  
  Because using male only will be beneficial (because the combination of two drugs is new) so we can
  expect lower variation in PK result, but we can not assess gender difference. But if one also
  includes female, higher number of subjects will be needed.
  
  I am looking forward to hearing from you guys.
  
  Best regards,
  riswanto
  
  

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