PharmPK Discussion - 90% CI of ratio of SDs for NTI drugs

• On 16 Jul 2015 at 08:56:35, akasam satishkumar (akasamsatishkumar.at.gmail.com sent the message
  

  
  Dear all,
  
  As we know for NTI drugs guidelines Warfarin has suggested that use both (1) scaled and unscaled
  ABE, in addition to that (2) calculation of 90% CI of ratio of within subject standard deviation of
  test to reference product.
  
  Here my problem is (2). i don't know how to calculate (2). but i tried it with 'COVPRMS' of 'PROC
  MIXED' from normal ln transformed data (not from ilat, dlat). i calculated within subject standard
  deviation for test and reference using 'estimates' in 'COVPRMS'. now i just want to know am i doing
  it in the correct way or not?
  
  Thanks and Regards,
  Satish.
  
  [NTI? - db]
  
  

  Back to the Top

• On 16 Jul 2015 at 11:40:04, nanzh.at.UMICH.EDU sent the message
  

  
  Satish,
  
  For (2), please refer to the BE recommendation for warfarin
  (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf)
  . It has a step-by-step instruction on how to use SAS to calculate the within subject variabilty.
  
  You can also refer the FDA guidance: statistical approaches to establish BE
  (http://www.fda.gov/downloads/Drugs/Guidances/ucm070244.pdf). The appendix contains instructions on
  how to calculate within subject standard deviation, if you are using other software.
  
  Sincerely,
  Nan
  
  

  Back to the Top

Copyright 1995-2014 David W. A. Bourne (david@boomer.org)