Bioequivalence and Bioavailability Forum

Dear Joy,

first see this post. A potency correction was one of the discussion points for the revison of the guideline (the draft was adopted on July 24^th, 2008 by EMEA's CHMP - see this post).
Since the potency correction was dropped from WHO's guideline in 2006, don't expect it in the drafted EU-guideline. From personal communications with members of the EWP/PK group I reconstruct the argument against a correction as follows:
  > The analytical method has some documented variability.
  > It's possible in a fraudulent way to reanalyse the study's IMPs after the biostudy was evaluated
    until by simple chance their content will come up in such a way that it would 'safe' an already
    failed study.
Although a prerequisite of BE is GMP (including documented release of IMPs) which should prevent such a thing, that's the currenty thinking in the EU (paranoia? In practice in Canada since 1992).
For details join the party of people waiting for the draft to be published on EMEA's website.