PharmPK Discussion - Assessment of dose proportionality

• On 19 Jan 2007 at 11:05:22, "Charlie Brindley" (charlie.brindley.at.kinetassist.com) sent the message
  

  
  We would be very grateful if you could spare 2 minutes to help us
  with a survey on the currently used methodology to assess dose
  proportionality in clinical trials (specifically first in human
  studies or similar Phase I dose escalation studies, but excluding
  Phase II-III studies).  We aim to post the results on PharmPK and
  incorporate them in a review article on dose proportionality for the
  PSI journal Pharmaceutical Statistics.
  
  1. What methodology do you use for assessing dose proportionality?
  a)  dose normalization of PK parameters followed by a test for
  overall differences (eg F test from ANOVA)
  b) dose normalization of PK parameters followed by pair wise tests
  for differences  (eg t tests from ANOVA)
  c)  estimation of exponent beta from power model (i.e. fitting linear
  regression to logged data and estimating the slope)
  d)  estimation of exponent beta with confidence interval (CI) from
  power model
  e) any other: please specify
  f) none
  
  2. If you use the power model under what circumstances do you
  conclude dose proportionality:
  a) Exponent beta estimate close to one
  b) CI around exponent beta includes unity
  c) CI around exponent beta within pre-specified limits based on the
  criterion proposed by Smith et al (2000), ie [1+ln(thetaL)/ln(r), 1+ln
  (thetaU)/ln(r)], using values thetaL=0.8 and thetaU=1.25
  d) CI around exponent beta within other pre-specified limits: please
  specify
  e) any other: please specify
  
  Responses can be made to PharmPK or directly to
  Charlie.Brindley.-a-.kinetAssist.com.  Responses received by Thursday
  22nd February will be collated and posted on PharmPK.  We can
  guarantee that all responses will remain anonymous and only summaries
  shown.
  Thank you for your help,
  Charlie Brindley, Jurgen Hummel, Ray French and Sue McKendrick
  
  [Responses are best sent to Charlie.Brindley.aaa.kinetAssist.com thanks -
  db]
  
  

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