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For US, Canada and many other countries the bioequivlence criteria is based
on 90% confidence intervals for Cmax,AUC to lie between 80-125% but we
would like to Know whether the same criteia holds good or any changes for
concluding bioequivalency as per european Community guidelines.
Thanks!
Bangaru
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Yes. Here is the website info for the EMEA's guidance on the subject.
http://dg3.eudra.org/eudralex/vol-3/home.htm scroll down to Volume
3C-Efficacy-Clinical Guidelines (General) select document number 3CC15A
entitled " Investigation of Bioavailability and Bioequivalence".
Sincerely, Katy
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Katy and others,
Although the web site to which you directed us has a document describing
bioequivalence in Europe, a more recent EMEA document proposed by the Committee
for Proprietary Medicinal Products (CPMP) is slightly different but apparently
is still a draft. It is titled "Note for Guidance on the Investigation of
Bioavailability and Bioequivalence" and may be found at the web site
http://www.edura.org/emea.html. Of interest with the draft guidance is a
statement in the Background Information which indicates a recent judgment of
the European Court of Justice in the "Generics" case (Case C-368/96) which
introduces a new definition of "essential similariaty". From reading the case,
I received the impression that tablets and capsules can no longer be considered
essentially similar products. The point is that in Europe it appears in the
past some pharmaceutical alternatives (i.e. capsules vs. tablets) could be
considered interchangeable, but the court ruling has changed that. Anyway, my
question is: In Europe can tablets and capsules be considered "essentially
similar"? Thanks in advance for any clarification.
Art Straughn
Professor and Director
Drug Delivery Research Laboratory
University of Tennessee
astraughn.at.utmem.edu
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Whether or not tablets and Capsules can/will be regarded as
essentially similar in Europe is a question about which country you
are referring to. In some of the European countries such similarity
has been accepted for years, while in other countries (as in my own
country, Norway) that has not been the case. This will of course
change as the process of harmonisation (and joint approval) is
completed, but for the now being one should still be aware of such
differences among the European countries.
Good luck
Nils Ove Hoem
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