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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 D. Pop
Pharma Medica Research Inc.
966 Pantera Drive
Canada, L4W 2S1
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