TY - STD TI - WHO Regional Committee for Africa Resolution AFR/RC58/R2: strengthening public health laboratories in the WHO African region: a critical need for disease control. In: WHO Regional Committee for Africa. Final Report: 58th Session of the WHO Regional Committee for Africa. WHO Regional Office for Africa, Brazzaville 2008; p. 11–13. ID - ref1 ER - TY - JOUR AU - Rishniw, M. a. r. k. AU - Pion, P. a. u. l. D. AU - Maher, T. a. m. m. y. PY - 2012 DA - 2012// TI - The quality of veterinary in-clinic and reference laboratory biochemical testing JO - Vet Clin Pathol VL - 41 ID - Rishniw2012 ER - TY - JOUR AU - Cho, M. C. AU - Kim, S. Y. AU - Jeong, T. D. AU - Lee, W. AU - Chun, S. AU - Min, W. K. PY - 2014 DA - 2014// TI - Statistical validation of reagent lot change in the clinical chemistry laboratory can confer insights on good clinical laboratory practice JO - Ann Clin Biochem VL - 51 UR - https://doi.org/10.1177/0004563214520749 DO - 10.1177/0004563214520749 ID - Cho2014 ER - TY - JOUR AU - Miller, W. G. AU - Erek, A. AU - Cunningham, T. D. AU - Oladipo, O. AU - Scott, M. G. AU - Johnson, R. E. PY - 2011 DA - 2011// TI - Commutability limitations influence quality control results with different reagent lots JO - Clin Chem VL - 57 UR - https://doi.org/10.1373/clinchem.2010.148106 DO - 10.1373/clinchem.2010.148106 ID - Miller2011 ER - TY - JOUR AU - Agarwal, R. AU - Chaturvedi, S. AU - Chhillar, N. AU - Goyal, R. AU - Pant, I. AU - Tripathi, C. B. PY - 2012 DA - 2012// TI - Role of intervention on laboratory performance: evaluation of quality indicators in a Tertiary Care Hospital JO - Indian J Clin Biochem VL - 27 UR - https://doi.org/10.1007/s12291-011-0182-7 DO - 10.1007/s12291-011-0182-7 ID - Agarwal2012 ER - TY - JOUR AU - Thompson, M. AU - Ellison, S. L. R. AU - Wood, R. PY - 2002 DA - 2002// TI - Harmonized guidelines for single-laboratory validation of methods of analysis. IUPAC technical report JO - Pure Appl Chem VL - 74 UR - https://doi.org/10.1351/pac200274050835 DO - 10.1351/pac200274050835 ID - Thompson2002 ER - TY - JOUR AU - Pasciu, V. AU - Baralla, E. AU - Nieddu, M. a. r. i. a. AU - Succu, S. AU - Porcu, C. AU - Leoni, G. G. AU - Sechi, P. AU - Bomboi, G. C. AU - Berlinguer, F. PY - 2019 DA - 2019// TI - Commercial human kits’ applicability for the determination of biochemical parameters in sheep plasma JO - J Vet Med Sci VL - 81 UR - https://doi.org/10.1292/jvms.18-0356 DO - 10.1292/jvms.18-0356 ID - Pasciu2019 ER - TY - STD TI - Guidance for industry bioanalytical method validation U.S. Department of Health and Human Services food and drug administration centre for drug evaluation and research (CDER) Center for Veterinary medicine (CVM). 2001. http://academy.gmp-compliance.org/guidemgr/files/4252FNL.PDF. Accessed 14 Dec 2020. UR - http://academy.gmp-compliance.org/guidemgr/files/4252FNL.PDF ID - ref8 ER - TY - STD TI - EMA Guideline on Bioanalytical Method Validation 2011. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf. Accessed 14 Dec 2020. UR - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf ID - ref9 ER - TY - JOUR AU - Mano, Y. PY - 2018 DA - 2018// TI - Method validation studies and an inter-laboratory cross validation study of lenvatinib assay in human plasma using LC-MS/MS JO - Pract Lab Med. VL - 12 UR - https://doi.org/10.1016/j.plabm.2018.e00103 DO - 10.1016/j.plabm.2018.e00103 ID - Mano2018 ER - TY - JOUR AU - Harr, K. E. AU - Flatland, B. AU - Nabity, M. AU - Freeman, K. P. PY - 2013 DA - 2013// TI - ASVCP guidelines: allowable total error guidelines for biochemistry JO - Vet Clin Pathol. VL - 42 UR - https://doi.org/10.1111/vcp.12101 DO - 10.1111/vcp.12101 ID - Harr2013 ER - TY - STD TI - OIE Validation Guidelines 2014 [Internet] Selection and use of reference samples and panels. https://www.oie.int/fileadmin/Home/eng/Health_standards/aahm/current/GUIDELINE_3.6.6_REFERENCE_SAMPLES.pdf. Accessed 14 Dec 2020. UR - https://www.oie.int/fileadmin/Home/eng/Health_standards/aahm/current/GUIDELINE_3.6.6_REFERENCE_SAMPLES.pdf ID - ref12 ER - TY - JOUR AU - Ferryanto, L. PY - 2015 DA - 2015// TI - Statistical sampling plan for design verification & validation of medical devices JO - J Valid Tech. VL - 21 ID - Ferryanto2015 ER - TY - CHAP AU - Westgard, J. O. ED - Westgard, J. O. PY - 2008 DA - 2008// TI - Method validation-the experimental plan BT - Basic Method Validation PB - Westgard QC, Inc CY - Madison ID - Westgard2008 ER - TY - CHAP AU - Westgard, J. O. ED - Westgard, J. O. PY - 2008 DA - 2008// TI - Method validation-the replication experiment BT - Basic Method Validation PB - Westgard QC, Inc CY - Madison ID - Westgard2008 ER - TY - JOUR AU - Lee, J. W. PY - 2006 DA - 2006// TI - Fit-for-purpose method development and validation for successful biomarker measurement JO - Phram Res VL - 23 UR - https://doi.org/10.1007/s11095-005-9045-3 DO - 10.1007/s11095-005-9045-3 ID - Lee2006 ER - TY - CHAP AU - Westgard, J. O. ED - Westgard, J. O. PY - 2008 DA - 2008// TI - Method validation-the interference and recovery experiments BT - Basic Method Validation PB - Westgard QC, Inc CY - Madison ID - Westgard2008 ER - TY - JOUR AU - Nevalainen, D. AU - Berte, L. AU - Kraft, C. AU - Leigh, E. AU - Picaso, L. AU - Morgan, T. PY - 2000 DA - 2000// TI - Evaluating laboratory performance on quality indicators with the six sigma scale JO - Arch Pathol Lab Med VL - 124 ID - Nevalainen2000 ER - TY - JOUR AU - Westgard, J. O. PY - 1995 DA - 1995// TI - A method evaluation decision chart (MEDx chart) for judging method performance JO - Clin Lab Sci VL - 8 ID - Westgard1995 ER - TY - JOUR AU - Westgard, J. O. AU - Westgard, S. A. PY - 2008 DA - 2008// TI - An assessment of σ metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance JO - J Vet Diagn Invest VL - 20 UR - https://doi.org/10.1177/104063870802000502 DO - 10.1177/104063870802000502 ID - Westgard2008 ER - TY - JOUR AU - Daniel, W. AU - Anders, K. AU - John, W. AU - Jan, S. AU - Kristen, M. PY - 2004 DA - 2004// TI - Evaluation of precision performance of quantitative measurement methods; Approved guideline JO - NCCLS Document EP5-A2. VL - 24 ID - Daniel2004 ER - TY - JOUR AU - Andreasson, U. AU - Perret-Liaudet, A. AU - Waalwijk Doorn, L. J. C. AU - Blennow, K. AU - Chiasserini, D. AU - Engelborghs, S. AU - Fladby, T. AU - Genc, S. AU - Kruse, N. AU - Kuiperij, H. B. AU - Kulic, L. AU - Lewczuk, P. AU - Mollenhauer, B. AU - Mroczko, B. AU - Parnetti, L. AU - Vanmechelen, E. AU - Verbeek, M. M. AU - Winblad, B. AU - Zetterberg, H. AU - Koel-Simmelink, M. AU - Teunissen, C. E. PY - 2015 DA - 2015// TI - A practical guide to immunoassay method validation JO - Front Neurol. VL - 19 ID - Andreasson2015 ER - TY - JOUR AU - Valentin, M. A. AU - Ma, S. AU - Zhao, A. AU - Legay, F. AU - Avrameas, A. PY - 2011 DA - 2011// TI - Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies JO - J Pharm Biomed Anal VL - 55 UR - https://doi.org/10.1016/j.jpba.2011.03.033 DO - 10.1016/j.jpba.2011.03.033 ID - Valentin2011 ER - TY - BOOK AU - Westgard, J. O. PY - 2006 DA - 2006// TI - Six sigma quality design and control PB - Westgard QC Inc. CY - Madison ID - Westgard2006 ER - TY - JOUR AU - Westgard, J. O. AU - Westgard, S. A. PY - 2006 DA - 2006// TI - The quality of laboratory testing today an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA Criteria for Acceptable Performance JO - J Clin Pathol VL - 125 UR - https://doi.org/10.1309/V50H4FRVVWX12C79 DO - 10.1309/V50H4FRVVWX12C79 ID - Westgard2006 ER -