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The following message was posted to: PharmPK
Dear All,
Can anyone tell me the link to the Regulatory Guidance of Finland for
Bioavailability and Bioequivalence Requirements for Generic drugs?
Does Finland also follow the CPMP guidance ?
V. Madhuri
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The following message was posted to: PharmPK
Dear Madhuri!
Since Finland is a member of the European Union, the EMEA Note for
Guidance applies.
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf
One remark: there are rumors, that the guidelinde will be updated in
the near future (e.g., the extended acceptance range for Cmax will be
dropped). Finland was already very restrictive in that respect.
Regards
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at
Bioequivalence/Bioavailability Forum at http://forum.bebac.at http://
www.goldmark.org/netrants/no-word/attach.html
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