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Does anyone have any experience of conducting bioequivalence studies in
India for subsequent support of a submission in Europe and/or to the FDA for
a generic product? If so I would be grateful to hear of your experiences.
Linked to this theme is the question of whether much work has been carried
out on the differences in metabolism/P450s in the Indian population compared
with Caucasians. There are a few instances published but I would be
grateful to hear of any work in this area.
Many thanks in anticipation.
Michael G Neale
9 Welland Road, Barrow-upon-Soar
Loughborough, Leicestershire, LE12 8NA
Tel/Fax 01509 412204
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Dear Dr. Neale,
There are many centres in India which conduct Bioequivalence studies. Please
visit our website to know more about us. We are a CRO with European base at
Paris.
Website www.dagaonkar.com
Email drsudhir.aaa.bom2.vsnl.net.in
Dr.Sudhir V. Dagaonkar
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)