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Volumn 16, Issue 3, 2014, Pages 392-399

Stability: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team

Author keywords

GBC; regulated bioanalysis; stability assessment

Indexed keywords

ANALYTICAL PARAMETERS; CALIBRATION; CHROMATOGRAPHY; DRUG STABILITY; DRUG STORAGE; EXTRACT STABILITY; FREEZE THAWING; FROZEN SECTION; FROZEN STABILITY; HEMATOLOGICAL PARAMETERS; LIGAND BINDING; PARTICLE SIZE; PHYSICAL PARAMETERS; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REFERENCE VALUE; REPRODUCIBILITY; REVIEW; STOCK STABILITY; STORAGE TEMPERATURE; TISSUE STABILITY; URINE PH; URINE STABILITY; VALIDATION PROCESS; WHOLE BLOOD STABILITY; DRUG INDUSTRY; FREEZING; HUMAN; STANDARD; STANDARDS;

EID: 84900334724     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9573-z     Document Type: Review
Times cited : (65)

References (17)
  • 1
    • 0026336726 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. Conference report
    • Shah VP, Midha KK, Dighe S, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. Eur J Drug Metab Pharmacokinet. 1991;16:249-55.
    • (1991) Eur J Drug Metab Pharmacokinet , vol.16 , pp. 249-255
    • Shah, V.P.1    Midha, K.K.2    Dighe, S.3
  • 3
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine (2001) Guidance for industry: bioanalytical method validation
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 4
    • 81055146012 scopus 로고    scopus 로고
    • European Medicines Agency, Committee for Medicinal Products for Human Use
    • European Medicines Agency, Committee for Medicinal Products for Human Use (2011) Guideline on bioanalytical method validation
    • (2011) Guideline on Bioanalytical Method Validation
  • 5
    • 84888374189 scopus 로고    scopus 로고
    • Agência Nacional de Vigilância Sanitária, Brazil. May
    • Agência Nacional de Vigilância Sanitária, Brazil. Resolução - RDC No 27. May 2012.
    • (2012) Resolução - RDC No 27
  • 7
  • 9
    • 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. 2007;9:E109-14.
    • (2007) AAPS J , vol.9
    • Bansal, S.1    DeStefano, A.2
  • 10
    • 34247894006 scopus 로고    scopus 로고
    • Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples
    • DOI 10.1208/aapsj0902013, 13
    • Nowatzke W, Woolf E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J. 2007;9:E117-22. (Pubitemid 46690951)
    • (2007) AAPS Journal , vol.9 , Issue.2
    • Nowatzke, W.1    Woolf, E.2
  • 11
    • 79959421480 scopus 로고    scopus 로고
    • Recommendations on: Internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for bioanalysis
    • Lowes S, Jersey J, Shoup R, et al. Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for bioanalysis. Bioanalysis. 2011;3:1323-32.
    • (2011) Bioanalysis , vol.3 , pp. 1323-1332
    • Lowes, S.1    Jersey, J.2    Shoup, R.3
  • 12
    • 79959404112 scopus 로고    scopus 로고
    • Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis
    • Freisleben A, Brudny-Klöppel M, Mulder H, et al . Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis. Bioanalysis. 2011;3:1333-6.
    • (2011) Bioanalysis , vol.3 , pp. 1333-1336
    • Freisleben, A.1    Brudny-Klöppel, M.2    Mulder, H.3
  • 13
    • 84866891957 scopus 로고    scopus 로고
    • Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for bioanalysis (GCC)
    • Lowes S, Boterman M, Doig M, et al. Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for bioanalysis (GCC). Bioanalysis. 2012;4:2117-26.
    • (2012) Bioanalysis , vol.4 , pp. 2117-2126
    • Lowes, S.1    Boterman, M.2    Doig, M.3
  • 14
    • 84875029552 scopus 로고    scopus 로고
    • The European Bioanalysis Forum community 's evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation
    • Van Amsterdam P, Companjen A, Brudny-Kloeppel M, et al. The European Bioanalysis Forum community 's evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation. Bioanalysis. 2013;5:645-59.
    • (2013) Bioanalysis , vol.5 , pp. 645-659
    • Van Amsterdam, P.1    Companjen, A.2    Brudny-Kloeppel, M.3
  • 15
    • 81055133495 scopus 로고    scopus 로고
    • Anticoagulant counter ion impact on bioanalytical LC-MS/MS assay performance: Additional validation required?
    • Sennbro CJ, Knutsson M, Timmerman P, et al. Anticoagulant counter ion impact on bioanalytical LC-MS/MS assay performance: additional validation required? Bioanalysis. 2011;3:2389-91.
    • (2011) Bioanalysis , vol.3 , pp. 2389-2391
    • Sennbro, C.J.1    Knutsson, M.2    Timmerman, P.3
  • 16
    • 0021857544 scopus 로고
    • A new approach for dealing with the stability of drugs in biological fluids
    • DOI 10.1002/jps.2600740913
    • Timm U, Wall M, Dell D. A new approach for dealing with the stability of drugs in biological fluids. J Pharm Sci. 1985;74:972-7. (Pubitemid 15014141)
    • (1985) Journal of Pharmaceutical Sciences , vol.74 , Issue.9 , pp. 972-977
    • Timm, U.1    Wall, M.2    Dell, D.3
  • 17
    • 77953479450 scopus 로고    scopus 로고
    • Generic approach to validation of small-molecule LC-MS/MS biomarker assays
    • Houghton R, Horro Pita C, Ward I, Macarthur R. Generic approach to validation of small-molecule LC-MS/MS biomarker assays. Bioanalysis. 2009;1:1365-74.
    • (2009) Bioanalysis , vol.1 , pp. 1365-1374
    • Houghton, R.1    Horro Pita, C.2    Ward, I.3    Macarthur, R.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.