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Hi, this is another quick note to inform you of a bioequivalence
guidance "cheat sheet" I am making available, which I developed on my
own time. The summary covers FDA, TPD, and EMEA guidances on
bioequivalence. It's available for download at the bottom of this
(or you can just download it directly here: http://
If for some reason you have trouble downloading it, email me and I
can send you a copy.
The main topics covered are:
Standards for Bioequivalence, sampling scheme criteria, fasting vs.
fed, parent vs. metabolite, blinding and data analysis, reference
product, and combining studies.
The spreadsheet is updated to current guidances (as of 07-May-07) but
I make no promises in keeping it updated, and no guarantees regarding
its accuracy. Please don't use it in place of consulting the actual
guidances referenced. It is not exhaustive to all topics in
bioequivalence. There are many topics not covered, for instance,
biowaivers and inhaled products. If you can accept its shortcomings,
it might make life a bit easier if you have as poor a memory as I do.
David Dubins, B.A.Sc., Ph.D.
Allied Research International Inc - Cetero Research
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