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Dear All,
Is it possible to conduct a BE study with a reference product only
marketed in EU by following the guidelines as per TPD and HPFB for
Canadian submission.
Or
Is there any requirements to perform a BE study with the reference
product marketed in the same region (Canada)?
Please provide your inputs regarding the same.
Regards
Manukrishnan
Lambda-Chennai
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The following message was posted to: PharmPK
Dear Mr.Manukrishnan,
Canadian guidelines on Bioequivalence studies states that.
In bioequivalence studies, the reference product is:
1. Drug product that has been issued a notice of compliance
pursuant to section C.08.004 of the Food and Drug Regulations, and is
currently marketed in Canada by the innovator, or
2. Drug product acceptable to the Director.
Hence, you can conduct a BE study with a reference product acceptable to
the Director following guidelines of the Therapeutic Products
Directorate & Health Products and Food Branch, Canada.
Regards,
Dr.S.Gunasakaran,MBBS,MD
Medical Affairs
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