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Hello list members. I am a graduate student and was wondering if
anyone can recommend good references for learning about method
validation? I need to learn exactly what parameters need to be
validated and how this is commonly done. Any help would be much
appreciated.
Alene
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Dear Alene-
The basis in the US for bioanalytical method validation (determination
of drugs in plasma, serum, etc) is FDA guidance issued in 2001:
http://www.fda.gov/cder/guidance/4252fnl.htm
There is also a paper issued in 2007 from a Conference held in 2006
(Crystal City), but I don't have the reference on this computer;
another member probably can provide it. Those should get you started.
Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.at.elan.com
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Hi Alene,
Please follow FDA guidelines, Here is the link, FDA Guidance for
Industry: Bioanalytical Method Validation,
http://www.fda.gov/CDER/GUIDANCE/4252fnl.htm
Analytical Procedures and Methods Validation Chemistry, Manufacturing,
and Controls Documentation
http://www.fda.gov/CDER/GUIDANCE/2396dft.pdf
Regards
Venkatesh
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hi
http://www.emea.europa.eu/pdfs/human/ich/038195en.pdf
this may help you
regards
Sachin Ramrao Patil
Deptt of Pharm.Tech Formulations
NIPER, SAS Nagar
sachin_prits.at.yahoo.co.in
www.Pharmascires.com
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The following message was posted to: PharmPK
Dear Alene,
The main paper to consider from the 2006 Crystal City conference was
published in the American Association of Pharmaceutical Scientists
Journal:
AAPS (2007) 9(1) p E30.
I believe FDA expects the recommendations made there to be considered,
even though the guidance has not yet been updated.
The article is part of a special issue with a number of articles on
the same theme that may of use to you.
Patrice
ROTTAPHARM | MADAUS
R&D Division
Rottapharm Spa
Via Valosa di Sopra, 9
20052 Monza - ITALY
patrice.larger.at.rottapharm.com
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The following message was posted to: PharmPK
Dear Alene,
the "Arlington Conference III White Paper" mentioned already by other
members is available at
http://www.aapsj.org/articles/aapsj0901/aapsj0901004/aapsj0901004.pdf
Best regards,
Helmut
-
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.-a-.bebac.at
web http://bebac.at/
contact http://bebac.at/Contact.htm
forum http://forum.bebac.at
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