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Hi,
I have tried to bring the guidance documents of
various regulatory agencies under one page, so that
everyone can easily access the documents without
getting lost in the web....
Links are as follows
http://www.geocities.com/ganaish/gansbioequivalence
http://www.geocities.com/ganaish/gansbio2
Hope you will find it useful.
Regards
Ganesh
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Dear Ganesh,
do not forget the biggest economy (population 450 millions) within the ICH, Europe ;-)
Guidelines are published by the European medicines Agency (EMEA)
http://www.emea.eu.int/
BA/BE
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf
MR
http://www.emea.eu.int/pdfs/human/ewp/028096en.pdf
Topicals
http://www.emea.eu.int/pdfs/human/ewp/023995en.pdf
Fixed Combination Products
http://www.emea.eu.int/pdfs/human/ewp/024095en.pdf
Interactions
http://www.emea.eu.int/pdfs/human/ewp/056095en.pdf
Efficacy Working Party:
Adopted Guidelines
http://www.emea.eu.int/htms/human/ewp/ewpfin.htm
Drafted Guidelines
http://www.emea.eu.int/htms/human/ewp/ewpdraft.htm
Points to Consider
http://www.emea.eu.int/htms/human/ewp/ewpptc.htm
Regards,
Helmut
Helmut Schutz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
A-1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at http://forum.bebac.at
http://www.goldmark.org/netrants/no-word/attach.html
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