Article View: sci.chem
Article #2349Re: Validation
From: Rick Venable
Date: Thu, 12 Jan 1995 20:51
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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arc1-ca.pugleaf.net!nntp.gmd.de!Germany.EU.net!howland.reston.ans.net!swrinde!gatech!darwin.sura.net!nih-csl!rvenableReferences:
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X-Google-Language: ENGLISH,ASCII-7-bit X-Google-Thread: f4886,986f5d179dd83830,start X-Google-Attributes: gidf4886,public X-Google-Thread: fd251,986f5d179dd83830,start X-Google-Attributes: gidfd251,public X-Google-ArrivalTime: 1995-01-12 12:51:54 PST Newsgroups: sci.chem,bionet.structural-nmr Path: arc1-ca.pugleaf.net!nntp.gmd.de!Germany.EU.net!howland.reston.ans.net!swrinde!gatech!darwin.sura.net!nih-csl!rvenable From: rvenable@deimos.cber.nih.gov (Rick Venable) Subject: Re: Validation Message-ID: <1995Jan12.205154.14584@alw.nih.gov> Followup-To: sci.chem,bionet.structural-nmr Sender: postman@alw.nih.gov (AMDS Postmaster) Organization: FDA/CBER Biophysics Lab X-Newsreader: TIN [version 1.2 PL2] References: <NEWTNews.22620.789948993.breffni@SLIP.technet.sg> Date: Thu, 12 Jan 1995 20:51:54 GMT Lines: 18