中图分类号:
R917
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参考文献
[1] VISWANATHAN C T. Incurred sample reanalysis: A global transformation . Bioanalysis, 2011, 3(23): 2601-2602.[2] ROCCI M L J R, DEVANNARAYAN V, HAUGHEY D B, et al. Confirmatory reanalysis of incurred bioanalytical samples . AAPS J, 2007, 9(3): 336-343.[3] European Medicines Agency. Guideline on bioanalytical method validation . 2011, 13-14.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf[4] ZHONG D F, LI G, LIU C X. Guidance on bioanalysis: Method validation and analysis of study samples (draft). Drug Eval Res(药物评价研究), 2011, 34(6): 409-415.[5] US Food and Drug Administration. Guidance for Industry Bioanalytical Method Validation . 2013, 18-19.http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm[6] MENG M, REUSCHEL S, BENNETT P. Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO . Bioanalysis, 2011, 3(4): 449-465.[7] YADAV M, SHRIVASTAV P S. Incurred sample reanalysis (ISR): A decisive tool in bioanalytical research . Bioanalysis, 2011, 3(9): 1007-1024.[8] TIMMERMAN P, LUEDTKE S, VAN AMSTERDAM P, et al. Incurred sample reproducibility: Views and recommendations by the European Bioanalysis Forum . Bioanalysis, 2009, 1(6): 1049-1056.[9] MEESTERS R J W, HOOFF G P, GRUTERS R, et al. Incurred sample reanalysis comparison of dried blood spots and plasma samples on the measurement of lopinavir in clinical samples.Bioanalysis, 2012, 3(4): 237-240. TAN A M, HUSSAIN S, MUSUKU A, et al. Internal standard response variations during incurred sample analysis by LC-MS/MS: Case by case trouble-shooting . J Chromatogr B, 2009, 877(27): 3201-3209. ROCCI M L J R, COLLINS E, WAGNER-CARUSO K E, et al. Investigation and resolution of incurred sample reanalysis failures: Two case studies . Bioanalysis, 2011, 3(9): 993-1000. FU Y L, LI W K, SMITH H T, et al. An investigation of incurred human urine sample reanalysis failure . Bioanalysis, 2011, 3(9): 967-972. GAROFOLO F, BERGERON A, SAVOIE N. How to manage having no incurred sample reanalysis evaluation failures . Bioanalysis, 2011, 3(9): 935-938. TAILLON M P, COTE C, FURTADO M, et al. Potentially new isobaric metabolite of fluvastatin observed by LC-MS/MS during incurred sample analysis . Bioanalysis, 2011, 3(16): 1827-1835. TAN A M, JIN W, DENG F, et al. Bioanalytical method development and validation using incurred samples(Simultaneous quantitation of ramipril and ramiprilat in human EDTA plasma by LC-MS/MS . J Chromatogr B, 2009, 877(29): 3673-3680. COTE C, LAHAIE M, LATOUR S, et al. Impact of methylation of acyglucuronide metabolites on incurred sample reanalysis evaluation: Ramiprilat case study . Bioanalysis, 2011, 3(9): 951-965. VOICU V, GHEORGHE M C, SORA I D, et al. Incurred sample reanalysis: Different evaluation approaches on data obtained for spironolactone and its active metabolite canrenone . Bioanalysis, 2011, 3(12): 1343-1356. JEMAL M, OUYANG Z, XIA Y Q. Systemic LC-MS/MS bioanalytical method development that incorporates plasma phospholipids risk avoidance, usage of incurred sample and well thought-out chromatography . Biomed Chromatogr, 2010, 24(1): 2-19. TAN A M, GAGNON-CARIGNAN S, LACHANCE S, et al. Beyond successful ISR: Case-by-case investigations for unmatched reassay results when ISR passed . Bioanalysis, 2011, 3(9): 1031-1038. DICAIRE C, BERUBE E R, DUMONT I, et al. Impact of oxcarbazepine sulfate metabolite on incurred sample reanalysis and quantification of oxcarbazepine. Bioanalysis, 2011, 3(9): 973-982. TANG D, THOMAS E. Strategies for dealing with hemolyzed samples in regulated LC-MS/MS bioanalysis . Bioanalysis, 2012, 4(22): 2715-2724. SRINIVAS N R. Incurred sample reanalysis: Dilemma in its applicability(should it be practiced for all bioanalytical assays involving single (parent or metabolite) or multiple analytes (parent/metabolite or parent with co-administered drugs) . Biomed Chromatogr, 2011, 25(6): 737-739.
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