PharmPK Discussion - Study requirements in Canada

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On 22 Nov 2003 at 13:48:30, RPop.aaa.pharmamedica.com sent the message


Hi Vardhini,
1) I saw that you received the link to Canada's TPD website.

2) TPD released a policy regarding acceptance rules for a BE study
perform with a reference drug-product not marketed in Canada. It should
be on the same web site.

3) You cannot know the manufacturing processes of the innovator. This
is protected information.

Hope this helps,
radu

Radu D. Pop
Director Biopharmaceutics
Pharma Medica Research Inc.

966 Pantera Drive
Mississauga, Ontario
Canada, L4W 2S1

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