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Article #2349

Re: Validation

#2349
From: Rick Venable
Date: Thu, 12 Jan 1995 20:51
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On Thu, 12 Jan 95 14:13:20 PDT BM@SLIP.technet.sg pontificated:
> Analytical method validation is described in the USP (for drugs)
> Can anybody suggest a more detailed source of information, both 
> theoretical/practical

There's a U.S. organization abreviated as A.O.A.C. which has published
information on analytcal method validation.  In particular, they recommend
cross-laboratory studies, as well as providing a simple methodology for
"ruggedness" testing of a method.  I believe the abbreviation stands for
the "Association of Official Analytical Chemists"; they used to sell a
small pamphlet sized handbook on statistical methods to be used for planning
and evaluating collaborative tests.

--
Rick Venable                  =====\     |=|    "Eschew Obfuscation"
FDA/CBER Biophysics Lab       |____/     |=|
Bethesda, MD  U.S.A.          |   \  /   |=|  / Not an official statement \
rvenable@deimos.cber.nih.gov       \/    |=|  \  or position of the FDA.  /
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From: rvenable@deimos.cber.nih.gov (Rick Venable)
Subject: Re: Validation
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Date: Thu, 12 Jan 1995 20:51:54 GMT
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