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Hi every one,
I am working on designing a BE study of oral solid dosage form for
Australian submission.
It would be much appreciated, if any one could provide information
regarding the official website/ submission guidelines/ BE acceptance
criteria for Australian submission
Thanks in advance.
Sincerely,
Niraj
Niraj Shethji
Pharmacokinetic Associate
Biovail Contract Research
Toronto, Canada
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The following message was posted to: PharmPK
Hi,
Here the website of the australian authority. you might find the
guideline there.
http://www.tga.gov.au/;
Regards,
Anna-Maria
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The following message was posted to: PharmPK
Hi Niraj,
Australia adopted the European Guideline in 2002
with the addition:
'The procedure for abridged applications claiming essential
similarity to a reference product (ie, generics), which
allows applications to be made to numerous Member States
of the EU, based on bioequivalence with a reference product
from one Member State, does not apply in Australia.
An application for registration of a generic product in
Australia should generally include a bioequivalence study
versus a leading brand obtained in Australia.'
You can find the guideline at:
http://www.tga.gov.au/docs/pdf/euguide/ewp/140198entga.pdf
Best regards
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
A-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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