메뉴 건너뛰기




Volumn 4, Issue 15, 2012, Pages 1919-1931

Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BLUNDER; CODING AND CLASSIFICATION; CONTROLLED STUDY; DRUG ANALYSIS; DRUG BIOANALYSIS; DRUG MONITORING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; INTERMETHOD COMPARISON; NOMENCLATURE; PRACTICE GUIDELINE; RANDOM ERROR; REVIEW; SAMPLE; SYSTEMATIC ERROR; THERAPEUTIC DRUG MANAGEMENT; UNITED STATES; VALIDATION PROCESS;

EID: 84865768355     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.157     Document Type: Review
Times cited : (10)

References (69)
  • 1
    • 77954697530 scopus 로고    scopus 로고
    • Development of bioanalysis: A short history
    • Hill HM. Development of bioanalysis: A short history. Bioanalysis 1(1), 3-7 (2009
    • (2009) Bioanalysis , vol.1 , Issue.1 , pp. 3-7
    • Hill, H.M.1
  • 4
    • 79955374769 scopus 로고    scopus 로고
    • Historical perspective on the development and evolution of bioanalytical guidance and technology
    • Shah VP, Bansal S. Historical perspective on the development and evolution of bioanalytical guidance and technology. Bioanalysis 3(8), 823-827 (2011
    • (2011) Bioanalysis , vol.3 , Issue.8 , pp. 823-827
    • Shah, V.P.1    Bansal, S.2
  • 5
    • 33847184252 scopus 로고    scopus 로고
    • Workshop/conference report - Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
    • DOI 10.1208/aapsj0901004, 4
    • Viswanathan CT, Bansal S, Booth B et al. Workshop/conference report - quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. AAPS J. 9(1), E30-E42 (2007). Updated and clarified many regulated drug bioanalysis issues. (Pubitemid 46296546)
    • (2007) AAPS Journal , vol.9 , Issue.1
    • Viswanathan, C.T.1    Bansal, S.2    Booth, B.3    DeStefano, A.J.4    Rose, M.J.5    Sailstad, J.6    Shah, V.P.7    Skelly, J.P.8    Swann, P.G.9    Weiner, R.10
  • 6
    • 68249147642 scopus 로고    scopus 로고
    • Workshop report and follow-up - AAPS workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples - implications of Crystal City Recommendations
    • Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up - AAPS workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples - implications of Crystal City Recommendations. AAPS J. 11(2), 238-241 (2009
    • (2009) AAPS J. , vol.11 , Issue.2 , pp. 238-241
    • Fast, D.M.1    Kelley, M.2    Viswanathan, C.T.3
  • 7
    • 79951747555 scopus 로고    scopus 로고
    • Building the global bioanalysis consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation
    • van Amsterdam P, Arnold M, Bansal S et al. Building the global bioanalysis consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation. Bioanalysis 2(11), 1801-1803 (2010
    • (2010) Bioanalysis , vol.2 , Issue.11 , pp. 1801-1803
    • Van Amsterdam, P.1    Arnold, M.2    Bansal, S.3
  • 8
    • 79951743532 scopus 로고    scopus 로고
    • International harmonization of bioanalytical guidance
    • Bansal SK, Arnold M, Garofolo F. International harmonization of bioanalytical guidance. Bioanalysis 2(4), 685-687 (2010
    • (2010) Bioanalysis , vol.2 , Issue.4 , pp. 685-687
    • Bansal, S.K.1    Arnold, M.2    Garofolo, F.3
  • 9
    • 84856850874 scopus 로고    scopus 로고
    • US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium
    • Garofolo F, Michon J, Leclaire V et al. US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium. Bioanalysis 4(3), 231-236 (2012
    • (2012) Bioanalysis , vol.4 , Issue.3 , pp. 231-236
    • Garofolo, F.1    Michon, J.2    Leclaire, V.3
  • 10
    • 77950364863 scopus 로고    scopus 로고
    • The evolution of mass spectrometry in the clinical laboratory
    • Hammett-Stabler CA, Garg U. The evolution of mass spectrometry in the clinical laboratory. Methods Mol. Biol. 603, 1-7 (2010
    • (2010) Methods Mol. Biol. , vol.603 , pp. 1-7
    • Hammett-Stabler, C.A.1    Garg, U.2
  • 11
    • 84865721338 scopus 로고    scopus 로고
    • Approved Guideline - Second Edition. Clinical and Laboratory Standards Institute
    • Lasky FD, Kroll MH, Tholen DW. Evaluation of Matrix Effects; Approved Guideline - Second Edition. Clinical and Laboratory Standards Institute 25(4), EP14-A2 (2005
    • (2005) Evaluation of Matrix Effects , vol.25 , Issue.4
    • Lasky, F.D.1    Kroll, M.H.2    Tholen, D.W.3
  • 14
    • 0036310862 scopus 로고    scopus 로고
    • Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)
    • A harmonized guidance for a general method validation (International Union of Pure and Applied Chemistry, International Organization for Standardization and International Association of Official Analytical Chemists)
    • Thompson M, Ellison SLR, Wood R. Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report). Pure Appl. Chem. 74(5), 835-855 (2002). A harmonized guidance for a general method validation (International Union of Pure and Applied Chemistry, International Organization for Standardization and International Association of Official Analytical Chemists
    • (2002) Pure Appl. Chem. , vol.74 , Issue.5 , pp. 835-855
    • Thompson, M.1    Ellison, S.L.R.2    Wood, R.3
  • 17
    • 0034771575 scopus 로고    scopus 로고
    • The use of selectivity in analytical chemistry - Some considerations
    • DOI 10.1016/S0165-9936(01)00093-0, PII S0165993601000930
    • Persson BA, Vessman J. The use of selectivity in analytical chemistry - some considerations. Trends Anal. Chem. 20, 526-532 (2001 (Pubitemid 33000322)
    • (2001) TrAC - Trends in Analytical Chemistry , vol.20 , Issue.10 , pp. 526-532
    • Persson, B.-A.1    Vessman, J.2
  • 18
    • 0025903573 scopus 로고
    • Validation of bioanalytical methods
    • Early conceptual paper for bioanalytical method validation.
    • Karnes HT, Shiu G, Shah VP. Validation of bioanalytical methods. Pharm. Res. 8(4), 421-426 (1991). Early conceptual paper for bioanalytical method validation.
    • (1991) Pharm. Res. , vol.8 , Issue.4 , pp. 421-426
    • Karnes, H.T.1    Shiu, G.2    Shah, V.P.3
  • 19
    • 0034178168 scopus 로고    scopus 로고
    • Selectivity versus specificity in chromatographic analytical methods
    • Aboul-Enein AH. Selectivity versus specificity in chromatographic analytical methods. Accred. Qual. Assur. 5, 180-181 (2000
    • (2000) Accred. Qual. Assur. , vol.5 , pp. 180-181
    • Aboul-Enein, A.H.1
  • 21
    • 84863163472 scopus 로고    scopus 로고
    • Matrix effect and recovery terminology issues in regulated drug bioanalysis
    • Huang Y, Shi R, Gee W, Bonderud R. Matrix effect and recovery terminology issues in regulated drug bioanalysis. Bioanalysis 4(3), 271-279 (2012
    • (2012) Bioanalysis , vol.4 , Issue.3 , pp. 271-279
    • Huang, Y.1    Shi, R.2    Gee, W.3    Bonderud, R.4
  • 22
    • 0004263460 scopus 로고    scopus 로고
    • 3rd Edition. Westgard QC Inc., WI USA, Key book of basic method validation for the clinical laboratory.
    • Westgard JO. In: Basic Method Validation. 3rd Edition. Westgard QC, Inc., WI, USA (2008). Key book of basic method validation for the clinical laboratory.
    • (2008) Basic Method Validation
    • Westgard, J.O.1
  • 24
    • 79951769600 scopus 로고    scopus 로고
    • 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop
    • Savoie N, Garofolo F, van Amsterdam P et al. 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop. Bioanalysis 2(1), 53-68 (2010
    • (2010) Bioanalysis , vol.2 , Issue.1 , pp. 53-68
    • Savoie, N.1    Garofolo, F.2    Van Amsterdam, P.3
  • 25
    • 79951768879 scopus 로고    scopus 로고
    • The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis
    • Savoie N, Booth BP, Bradley T et al. The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis. Bioanalysis 1(1), 19-30 (2009
    • (2009) Bioanalysis , vol.1 , Issue.1 , pp. 19-30
    • Savoie, N.1    Booth, B.P.2    Bradley, T.3
  • 26
    • 0007450684 scopus 로고
    • Hemolytic effect of therapeutic drugs. Clinical considerations of the primaquine-type hemolysis
    • Kellermeyer RW, Tarlov AR, Brewer GJ, Carson PE, Alving AS. Hemolytic effect of therapeutic drugs. Clinical considerations of the primaquine-type hemolysis. JAMA 180, 388-394 (1962
    • (1962) JAMA , vol.180 , pp. 388-394
    • Kellermeyer, R.W.1    Tarlov, A.R.2    Brewer, G.J.3    Carson, P.E.4    Alving, A.S.5
  • 28
    • 0033972513 scopus 로고    scopus 로고
    • Hemolyzed specimens: A reason for rejection or a clinical challenge? [3]
    • Carraro P. Hemolyzed Specimens: A reason for rejection or a clinical challenge? Clin. Chem. 46, 306-307 (2000 (Pubitemid 30104266)
    • (2000) Clinical Chemistry , vol.46 , Issue.2 , pp. 306-307
    • Carraro, P.1    Servidio, G.2    Plebani, M.3
  • 30
    • 0028197202 scopus 로고
    • An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies
    • DOI 10.1023/A:1018922701174
    • Kringle RO. An assessment of the 4-6-20 rule for acceptance of analytical runs in bioavailability, bioequivalence, and pharmacokinetic studies. Pharm. Res. 11, 556-560 (1994 (Pubitemid 24144449)
    • (1994) Pharmaceutical Research , vol.11 , Issue.4 , pp. 556-560
    • Kringle, R.O.1
  • 31
    • 0027973614 scopus 로고
    • An analysis of the Washington Conference Report on bioanalytical method validation
    • DOI 10.1016/0731-7085(94)00083-2
    • Hartmann C, Massart DL, McDowall RD. An analysis of the Washington Conference Report on bioanalytical method validation. J. Pharm. Biomed. Anal. 12, 1337-1343 (1994 (Pubitemid 24339384)
    • (1994) Journal of Pharmaceutical and Biomedical Analysis , vol.12 , Issue.11 , pp. 1337-1343
    • Hartmann, C.1    Massart, D.L.2    McDowall, R.D.3
  • 32
    • 67650476312 scopus 로고    scopus 로고
    • A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation
    • Boulanger B, Rozet E, Moonen F, Rudaz S, Hubert P. A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877(23), 2235-2243 (2009
    • (2009) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. , vol.877 , Issue.23 , pp. 2235-2243
    • Boulanger, B.1    Rozet, E.2    Moonen, F.3    Rudaz, S.4    Hubert, P.5
  • 33
    • 34249083153 scopus 로고    scopus 로고
    • A total error approach for the validation of quantitative analytical methods
    • DOI 10.1007/s11095-007-9242-3
    • Hoffman D, Kringle R. A total error approach for the validation of quantitative analytical methods. Pharm. Res. 24(6), 1157-1164 (2007 (Pubitemid 46798895)
    • (2007) Pharmaceutical Research , vol.24 , Issue.6 , pp. 1157-1164
    • Hoffman, D.1    Kringle, R.2
  • 34
    • 34247843033 scopus 로고    scopus 로고
    • Key elements of bioanalytical method validation for small molecules
    • Bansal S, DeStefano A. Key elements of bioanalytical method validation for small molecules. AAPS J. 9(1), E109-E114 (2007
    • (2007) AAPS J , vol.9 , Issue.1
    • Bansal, S.1    DeStefano, A.2
  • 35
    • 79952016469 scopus 로고    scopus 로고
    • Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO
    • Meng M, Reuschel S, Bennett P. Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO. Bioanalysis 3(4), 449-465 (2011
    • (2011) Bioanalysis , vol.3 , Issue.4 , pp. 449-465
    • Meng, M.1    Reuschel, S.2    Bennett, P.3
  • 36
    • 80052542955 scopus 로고    scopus 로고
    • Incurred sample reanalysis (ISR): A decisive tool in bioanalytical research
    • Yadav M, Shrivastav PS. Incurred sample reanalysis (ISR): A decisive tool in bioanalytical research. Bioanalysis 3(9), 1007-1024 (2011
    • (2011) Bioanalysis , vol.3 , Issue.9 , pp. 1007-1024
    • Yadav, M.1    Shrivastav, P.S.2
  • 37
    • 76549221753 scopus 로고
    • The use of control charts in the clinical laboratory
    • Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am. J. Clin. Pathol. 20(11), 1059-1066 (1950
    • (1950) Am. J. Clin. Pathol. , vol.20 , Issue.11 , pp. 1059-1066
    • Levey, S.1    Jennings, E.R.2
  • 38
    • 0019796502 scopus 로고
    • A multi-rule Shewhart chart for quality control in clinical chemistry
    • Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin. Chem. 27(3), 493-501 (1981
    • (1981) Clin. Chem. , vol.27 , Issue.3 , pp. 493-501
    • Westgard, J.O.1    Barry, P.L.2    Hunt, M.R.3    Groth, T.4
  • 39
    • 0026769757 scopus 로고
    • Evaluation of the rigor and appropriateness of CLIA '88 toxicology proficiency testing standards
    • Jenny RW, Jackson KY. Evaluation of the rigor and appropriateness of CLIA '88 toxicology proficiency testing standards. Clin. Chem. 38(4), 496-500 (1992
    • (1992) Clin. Chem. , vol.38 , Issue.4 , pp. 496-500
    • Jenny, R.W.1    Jackson, K.Y.2
  • 40
    • 78751644504 scopus 로고    scopus 로고
    • Adherence to HIV therapeutic drug monitoring guidelines in The Netherlands
    • van Luin M, Wit FW, Smit C et al. Adherence to HIV therapeutic drug monitoring guidelines in The Netherlands. Ther. Drug Monit. 33(1), 32-39 (2011
    • (2011) Ther. Drug Monit. , vol.33 , Issue.1 , pp. 32-39
    • Van Luin, M.1    Wit, F.W.2    Smit, C.3
  • 41
    • 33748177814 scopus 로고    scopus 로고
    • Quality assurance program for pharmacokinetic assay of antiretrovirals: ACTG proficiency testing for pediatric and adult pharmacology support laboratories, 2003 to 2004 - Requirement for therapeutic drug monitoring
    • DOI 10.1097/01.ftd.0000211817.58052.b8, PII 0000769120060600000016
    • Holland DT, DiFrancesco R, Connor JD, Morse GD. Quality assurance program for pharmacokinetic assay of antiretrovirals: ACTG proficiency testing for pediatric and adult pharmacology support laboratories, 2003 to 2004: A requirement for therapeutic drug monitoring. Ther. Drug Monit. 28(3), 367-374 (2006 (Pubitemid 44314924)
    • (2006) Therapeutic Drug Monitoring , vol.28 , Issue.3 , pp. 367-374
    • Holland, D.T.1    DiFrancesco, R.2    Connor, J.D.3    Morse, G.D.4
  • 44
    • 0031934505 scopus 로고    scopus 로고
    • Analytical goals in therapeutic drug monitoring
    • Bowers LD. Analytical goals in therapeutic drug monitoring. Clin. Chem. 44(2), 375-380 (1998 (Pubitemid 28087744)
    • (1998) Clinical Chemistry , vol.44 , Issue.2 , pp. 375-380
    • Bowers, L.D.1
  • 45
    • 0031900449 scopus 로고    scopus 로고
    • Laboratory guidelines for monitoring of antimicrobial drugs
    • Hammett-Stabler CA, Johns T. Laboratory guidelines for monitoring of antimicrobial drugs. National Academy of Clinical Biochemistry. Clin. Chem. 44(5), 1129-1140 (1998 (Pubitemid 28213161)
    • (1998) Clinical Chemistry , vol.44 , Issue.5 , pp. 1129-1140
    • Hammett-Stabler, C.A.1    Johns, T.2
  • 47
    • 80053292992 scopus 로고    scopus 로고
    • 2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections
    • Garofolo F, Rocci ML Jr, Dumont I et al. 2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections. Bioanalysis 3(18), 2081-2096 (2011
    • (2011) Bioanalysis , vol.3 , Issue.18 , pp. 2081-2096
    • Garofolo, F.1    Rocci Jr., M.L.2    Dumont, I.3
  • 48
    • 0038313971 scopus 로고
    • The randomized concentration-controlled clinical trial (CCT): An information-rich alternative to the randomized placebo controlled clinical trial (PCT)
    • Peck C. The randomized concentration-controlled clinical trial (CCT): An information-rich alternative to the randomized placebo controlled clinical trial (PCT). Clin. Pharmacol. Ther. 47, 148 (1990
    • (1990) Clin. Pharmacol. Ther. , vol.47 , pp. 148
    • Peck, C.1
  • 51
    • 0042833216 scopus 로고    scopus 로고
    • Randomized concentration-controlled trials: Motivations, use, and limitations
    • DOI 10.1016/S0009-9236(03)00169-3
    • Kraiczi H, Jang T, Ludden T, Peck CC. Randomized concentration-controlled trials: Motivations, use, and limitations. Clin. Pharmacol. Ther. 74(3), 203-214 (2003 (Pubitemid 37083096)
    • (2003) Clinical Pharmacology and Therapeutics , vol.74 , Issue.3 , pp. 203-214
    • Kraiczi, H.1    Jang, T.2    Ludden, T.3    Peck, C.C.4
  • 52
    • 0037469057 scopus 로고    scopus 로고
    • A phase III prospective, randomized study to evaluate concentration-controlled sirolimus (rapamune) with cyclosporine dose minimization or elimination at six months in de novo renal allograft recipients
    • DOI 10.1097/01.TP.0000063703.32564.3B
    • Baboolal K. A Phase III prospective, randomized study to evaluate concentration-controlled sirolimus (rapamune) with cyclosporine dose minimization or elimination at six months in de novo renal allograft recipients. Transplantation 75(8), 1404-1408 (2003 (Pubitemid 36513057)
    • (2003) Transplantation , vol.75 , Issue.8 , pp. 1404-1408
    • Baboolal, K.1
  • 54
    • 67651121813 scopus 로고    scopus 로고
    • Dried blood spot methods in therapeutic drug monitoring: Methods, assays, and pitfalls
    • Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: Methods, assays, and pitfalls. Ther. Drug Monit. 31(3), 327-336 (2009
    • (2009) Ther. Drug Monit. , vol.31 , Issue.3 , pp. 327-336
    • Edelbroek, P.M.1    Van Der Heijden, J.2    Stolk, L.M.3
  • 55
    • 59949083369 scopus 로고    scopus 로고
    • Measurement of xenobiotics in saliva: Is saliva an attractive alternative matrix? Case studies and analytical perspectives
    • Mullangi R, Agrawal S, Srinivas NR. Measurement of xenobiotics in saliva: Is saliva an attractive alternative matrix? Case studies and analytical perspectives. Biomed. Chromatogr. 23(1), 3-25 (2009
    • (2009) Biomed. Chromatogr. , vol.23 , Issue.1 , pp. 3-25
    • Mullangi, R.1    Agrawal, S.2    Srinivas, N.R.3
  • 56
    • 65349136347 scopus 로고    scopus 로고
    • Validation of a liquid chromatography-mass spectrometric assay for tacrolimus in peripheral blood mononuclear cells
    • Capron A, Musuamba F, Latinne D et al. Validation of a liquid chromatography-mass spectrometric assay for tacrolimus in peripheral blood mononuclear cells. Ther. Drug Monit. 31(2), 178-186 (2009
    • (2009) Ther. Drug Monit. , vol.31 , Issue.2 , pp. 178-186
    • Capron, A.1    Musuamba, F.2    Latinne, D.3
  • 57
    • 78650184669 scopus 로고    scopus 로고
    • Therapeutic drug monitoring by LC-MS/MS with special focus on anti-infective drugs
    • Müller DM, Rentsch KM. Therapeutic drug monitoring by LC-MS/MS with special focus on anti-infective drugs. Anal. Bioanal. Chem. 398(6), 2573-2594 (2010
    • (2010) Anal. Bioanal. Chem. , vol.398 , Issue.6 , pp. 2573-2594
    • Müller, D.M.1    Rentsch, K.M.2
  • 59
    • 0027234789 scopus 로고
    • Therapeutic drug monitoring in hair samples - Principles and practice
    • Uematsu T. Therapeutic drug monitoring in hair samples. Principles and practice. Clin. Pharmacokinet. 25(2), 83-87 (1993 (Pubitemid 23232388)
    • (1993) Clinical Pharmacokinetics , vol.25 , Issue.2 , pp. 83-87
    • Uematsu, T.1
  • 60
    • 58149265518 scopus 로고    scopus 로고
    • Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry
    • Huang Y, Gandhi M, Greenblatt RM, Gee W, Lin ET, Massenkoff N. Sensitive analysis of anti-HIV drugs, efavirenz, lopinavir and ritonavir, in human hair by liquid chromatography coupled with tandem mass spectrometry. Rapid Commun. Mass Spectrom. 22(21), 3401-3409 (2008
    • (2008) Rapid Commun. Mass Spectrom. , vol.22 , Issue.21 , pp. 3401-3409
    • Huang, Y.1    Gandhi, M.2    Greenblatt, R.M.3    Gee, W.4    Lin, E.T.5    Massenkoff, N.6
  • 61
    • 80255126279 scopus 로고    scopus 로고
    • Microanalysis of the antiretroviral nevirapine in human hair from HIV-infected patients by liquid chromatography-tandem mass spectrometry
    • Huang Y, Yang Q, Yoon K et al. Microanalysis of the antiretroviral nevirapine in human hair from HIV-infected patients by liquid chromatography-tandem mass spectrometry. Anal. Bioanal. Chem. 401(6), 1923-1933 (2011
    • (2011) Anal. Bioanal. Chem. , vol.401 , Issue.6 , pp. 1923-1933
    • Huang, Y.1    Yang, Q.2    Yoon, K.3
  • 62
    • 53249111167 scopus 로고    scopus 로고
    • Development and validation of a LC-MS/MS method for quantifying the next generation calcineurin inhibitor, voclosporin, in human whole blood
    • Handy R, Trepanier D, Scott G, Foster R, Freitag D. Development and validation of a LC-MS/MS method for quantifying the next generation calcineurin inhibitor, voclosporin, in human whole blood. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 874(1-2), 57-63 (2008
    • (2008) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. , vol.874 , Issue.1-2 , pp. 57-63
    • Handy, R.1    Trepanier, D.2    Scott, G.3    Foster, R.4    Freitag, D.5
  • 64
    • 16244395189 scopus 로고    scopus 로고
    • Validation of a practical liquid chomatography with ultraviolet detection method for quantification of whole-blood everolimus in a clinical TDM laboratory
    • DOI 10.1097/01.ftd.0000152681.13647.85
    • Boudennaia TY, Napoli KL. Validation of a practical liquid chomatography with ultraviolet detection method for quantification of whole-blood everolimus in a clinical TDM laboratory. Ther. Drug Monit. 27(2), 171-177 (2005 (Pubitemid 40463645)
    • (2005) Therapeutic Drug Monitoring , vol.27 , Issue.2 , pp. 171-177
    • Boudennaia, T.Y.1    Napoli, K.L.2
  • 65
    • 0033400708 scopus 로고    scopus 로고
    • Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine
    • Dybkaer R. Setting quality specifications for the future with newer approaches to defining uncertainty in laboratory medicine. Scand. J. Clin. Lab. Invest. 59(7), 579-583 (1999 (Pubitemid 30056756)
    • (1999) Scandinavian Journal of Clinical and Laboratory Investigation , vol.59 , Issue.7 , pp. 579-583
    • Dybkaer, R.1
  • 66
    • 9944255782 scopus 로고    scopus 로고
    • New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data
    • Feinberg M, Boulanger B, Dewé W, Hubert P. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Anal. Bioanal. Chem. 380(3), 502-514 (2004
    • (2004) Anal. Bioanal. Chem. , vol.380 , Issue.3 , pp. 502-514
    • Feinberg, M.1    Boulanger, B.2    Dewé, W.3    Hubert, P.4
  • 67
    • 79955480549 scopus 로고    scopus 로고
    • Advances in validation, risk and uncertainty assessment of bioanalytical methods
    • Rozet E, Marini RD, Ziemons E, Boulanger B, Hubert P. Advances in validation, risk and uncertainty assessment of bioanalytical methods. J. Pharm. Biomed. Anal. 55(4), 848-858 (2011
    • (2011) J. Pharm. Biomed. Anal. , vol.55 , Issue.4 , pp. 848-858
    • Rozet, E.1    Marini, R.D.2    Ziemons, E.3    Boulanger, B.4    Hubert, P.5
  • 68
    • 67650124266 scopus 로고    scopus 로고
    • A Proposed 'fixed' range decision criteria for transfer of bioanalytical methods
    • Shah KA, Karnes HT. A proposed 'fixed' range decision criteria for transfer of bioanalytical methods. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877(23), 2270-2274 (2009
    • (2009) J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. , vol.877 , Issue.23 , pp. 2270-2274
    • Shah, K.A.1    Karnes, H.T.2
  • 69
    • 73349122873 scopus 로고    scopus 로고
    • Statistical considerations for assessment of bioanalytical incurred sample reproducibility
    • Hoffman D. Statistical considerations for assessment of bioanalytical incurred sample reproducibility. AAPS J. 11, 570-580 (2009).
    • (2009) AAPS J , vol.11 , pp. 570-580
    • Hoffman, D.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.