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Dear David
I looking for the acceptance range for pharmacokinetic parameters
duringthe bioequivalence test(BE test) in USA, EU and Japan.
Specially I want to know that the acceptance range can be usednarrow
or wider range.
If it wil be true,
1. What kind of case can be used the range
2. What kind ofguidance about that
Could yo drop this questions in the discussion group email box?
Thanks a lot.
Joon Gyo Oh
Associate research scientist
Life Science R&D center, Drug discovery division
Formulation & Pharmaceutical engineering Lab.
TEL : 82-31-240-8450
FAX : 82-31-240-8490
e-mail : ohjg.-a-.skchemicals.com
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The following message was posted to: PharmPK
Joon,
An English translation of the Japanese "Guideline for Bioequivalence
Studies of Generic Products" (December 22, 1997) can be found
at http://www.nihs.go.jp/drug/be-guide(e)/Generic/be97E.pdf.
The range is 80-125% for AUC and Cmax (90% CI).
Some conditions, in vitro dissolution etc., are described for
avoiding large number of subjects in the Guideline.
I cannot deny any possibility of a wider range for an agent
with a wider therapeutic window. However I have not heard
any examples accepted.
See http://member.nifty.ne.jp/HAL1atNiftyWeb/gls-e.html
for a list of PK related guidelines/guidance.
Masaki Hiraoka
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)