PMID: 2100596Jan 1, 1990Paper

A practical approach to method validation in pharmaceutical analysis

Journal of Pharmaceutical and Biomedical Analysis
G P Carr, J C Wahlich

Abstract

Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice is provided on how validations should be conducted and what results should be expected. In this paper it is attempted to suggest some practical approaches to conducting validation and in particular to the determination of accuracy, linearity and limit of detection/quantitation.

References

Jan 1, 1990·Journal of Pharmaceutical and Biomedical Analysis·J C Wahlich, G P Carr

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Citations

Mar 18, 1994·Journal of Chromatography. B, Biomedical Applications·G Moachon, D Matinier
Jan 1, 1990·Journal of Pharmaceutical and Biomedical Analysis·J C Wahlich, G P Carr
Jan 1, 1993·Journal of Pharmaceutical and Biomedical Analysis·B I Knight, A G Davidson
Aug 1, 1993·Journal of Pharmaceutical and Biomedical Analysis·G Indrayanto, R Handayani
Feb 1, 1995·Journal of Pharmaceutical and Biomedical Analysis·D DadgarJ W Hooper
Jan 1, 1996·Journal of Pharmaceutical and Biomedical Analysis·C E Sänger-van de Griend, K Gröningsson
Nov 8, 1996·Journal of Chromatography. B, Biomedical Applications·F BressolleM Audran
Mar 15, 2001·Journal of Pharmaceutical and Biomedical Analysis·M ZecevićD Minic
Apr 21, 1998·Journal of Pharmaceutical and Biomedical Analysis·M L DumontG R Haggan
May 20, 1998·Journal of Pharmaceutical and Biomedical Analysis·N M VolpatoP Colombo
Jun 25, 1998·Journal of Pharmaceutical and Biomedical Analysis·C HartmannR D McDowall
Mar 7, 2000·Journal of Pharmaceutical and Biomedical Analysis·G García-EncinaL Martínez
Mar 12, 2002·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·C JiménezJ Segura
Jan 30, 2003·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·A GarcíaC Barbas
Jun 16, 2011·Expert Review of Pharmacoeconomics & Outcomes Research·Kristina GaruolieneAlan Haycox
Jun 29, 2004·Bioelectrochemistry·Nagwa Abo-el-Maali
May 24, 2005·Journal of Pharmaceutical and Biomedical Analysis·J J Berzas NevadoE Aguas Nuevo
Apr 27, 1999·Therapeutic Drug Monitoring·N RadembinoP Jaillon
Aug 1, 1995·British Journal of Haematology·M W StewartB Sykes
Nov 5, 2019·Food Chemistry·Yuanzhe WangRichard G Compton

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