Bioequivalence and Bioavailability Forum

Dear all,

at the
   EUFEPS Network Conference on New Regulations in Bioequivalence:
   Revised European CHMP Note for Guidance
in Bad Homburg on 17-18 June 2008 Vinod Shad (FIP Scientific Secretary) reported that conditions stated in FDA's Guideline (August 2000) were relaxed following recommendations of the WHO TRS 973, Annex 7 (May 2006).

New specifications are
   pH 1.2, 4.5 and 6.8 (instead of pH 7.4), and
   relative bioavailability of 85% (instead of 90%).

These changes are mainly without written documentation but have to be followed from now on. For an example where the new pH is mentioned see the recommendation on Bupropion.

For another reference see Lawrence Yu's presentation 'BCS Biowaiver Extension: Roles of Dissolution' given at the AAPS Workshop on Dissolution and QbD, April 29^th, 2008.