PharmPK Discussion - EU guidance on modified release - bioequivalence

• On 27 Oct 2004 at 09:12:09, "Neil Somers" (NeilS.at.cts.co.il) sent the message
  

  
  All,
  I'm looking for some clarification on the EMEA guidance on
  bioequivalence testing for modified release forms (CPMP/EWP/280/96 pg
  11).  We're working on a generic modified release formulation, where
  the data from the literature clearly indicates no food effect for the
  active ingredient.
  According to this guidance we need only perform a single dose, two way,
  high fat, crossover study.  I have three questions about this:
  1) What is the scientific basis for the decision to eliminate a two way
  fasting crossover study?
  2) Are the discussions that led to this guidance archived, either on
  the web or in a library?  For example the current version is listed as
  Draft 15, where is Draft 1-14 located?
  3) In what countries is this guidance accepted as the rule for studies.
  Thank you.
  Neil Somers
  Project Manager
  CTS Chemical Industries
  Kiryat Maalchi, Israel
  
  

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