PharmPK Discussion - BE Studies in UK & EU

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On 1 Jan 2004 at 22:20:50, vardhini kirthivas (vardhinikirthivas.at.yahoo.com) sent the message

Hi All,
First of all, Wishing you all a very happy and Prosperous New Year 2004.
Can someone plz help in finding out the following.
1. Where can i find Reference listed drugs (Innovator products) for BE
studies in EU and UK.
2. Is there any guidelines for performing BE studies in UK.
Thanks.
Vardhini

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On 3 Jan 2004 at 12:43:28, "Mitesh S Gandhi" (miteshg.-a-.glenmarkpharma.com) sent the message

Dear Vardhini
Website for guideline of performing BE studies for UK submission are
http://www.emea.eu.int/pdfs/human/qwp/060496en.pdf
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf
http://www.emea.eu.int/pdfs/human/ewp/028096en.pdf
Regards,
Mitesh Gandhi
Dept. of .Pharmacokinetics,
GLENMARK RESEARCH CENTRE

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