Scaled Average Concept in Bioequivalence Studies

Hi,

The following links are very useful to estimate the Scaled Average Bioequivalence Study procedures. This is an Hot topic in all the regulatory bodies for Highly Variable drugs.

http://www.aapspharmaceutica.com/inside/focus_groups/bioequiv/imagespdfs/Endrenyi2007.pdf

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_4_files/frame.htm

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_5_files/frame.htm

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_2_files/frame.htm

http://www.fda.gov/cder/audiences/iact/forum/200804_chandaroy.pdf#page=13

http://www.springerlink.com/content/u503p62056413677/fulltext.pdf

Note: All these are all a collection from all other sites.