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Volumn 2, Issue 6, 2010, Pages 1041-1049

Evaluation of an isochronic study design for long-term frozen stability investigation of drugs in biological matrices

Author keywords

[No Author keywords available]

Indexed keywords

EDETIC ACID; POLYPROPYLENE; DRUG;

EID: 78650648231     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.53     Document Type: Article
Times cited : (7)

References (33)
  • 1
    • 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. 9(2), E117-E122 (2007). (Pubitemid 46690951)
    • (2007) AAPS Journal , vol.9 , Issue.2
    • Nowatzke, W.1    Woolf, E.2
  • 3
    • 0026606194 scopus 로고
    • Analytical methods validation: Bioavailability bioequivalence and pharmacokinetic studies
    • Shah V, Midha K, Dighe S et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies Pharm. Res. 9(4), 588-592 (1992).
    • (1992) Pharm. Res. , vol.9 , Issue.4 , pp. 588-592
    • Shah, V.1    Midha, K.2    Dighe, S.3
  • 4
    • 0028936323 scopus 로고
    • Application issues in bioanalytical method validation sample analysis and data reporting
    • Dadgar D, Burnett PE, Choc MG, Gallicano K, Hooper JW. Application issues in bioanalytical method validation, sample analysis and data reporting. J. Pharm. Biomed. Anal. 13(2), 89-97 (1995).
    • (1995) J. Pharm. Biomed. Anal. , vol.13 , Issue.2 , pp. 89-97
    • Dadgar, D.1    Burnett, P.E.2    Choc, M.G.3    Gallicano, K.4    Hooper, J.W.5
  • 5
    • 0029551578 scopus 로고
    • Issues in evaluation of bioanalytical method selectivity and drug stability
    • DOI 10.1016/0731-7085(95)01634-1
    • Dadgar D, Burnett PE. Issues in evaluation of bioanalytical method selectivity and drug stability. J. Pharm. Biomed. Anal. 14(1-2), 23-31 (1995). (Pubitemid 26146012)
    • (1995) Journal of Pharmaceutical and Biomedical Analysis , vol.14 , Issue.1-2 , pp. 23-31
    • Dadgar, D.1    Burnett, P.E.2
  • 7
    • 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. 74(9), 972-977 (1985). (Pubitemid 15014141)
    • (1985) Journal of Pharmaceutical Sciences , vol.74 , Issue.9 , pp. 972-977
    • Timm, U.1    Wall, M.2    Dell, D.3
  • 8
    • 0032502859 scopus 로고    scopus 로고
    • Requirements for initial assay validation and publication in J. Chromatography B
    • DOI 10.1016/S0378-4347(98)00027-9, PII S0378434798000279
    • Lindner W, Wainer IW. Requirements for initial assay validation and publication in J Chromatography B. J. Chromatogr. B Biomed. Sci. Appl. 707(1-2), 1-2 (1998). (Pubitemid 28198030)
    • (1998) Journal of Chromatography B: Biomedical Applications , vol.707 , Issue.1-2 , pp. 1-2
    • Lindner, W.1    Wainer, I.W.2
  • 9
    • 33846075702 scopus 로고    scopus 로고
    • Validation of new methods
    • DOI 10.1016/j.forsciint.2006.05.021, PII S0379073806003239, Research in Forensic Medicine and Forensic Sciences: Basic Principles and Application in Practice
    • Peters FT, Drummer OH, Musshoff F. Validation of new methods. Forensic Sci. Int. 165(2-3), 216-224 (2007). (Pubitemid 46073540)
    • (2007) Forensic Science International , vol.165 , Issue.2-3 , pp. 216-224
    • Peters, F.T.1    Drummer, O.H.2    Musshoff, F.3
  • 10
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules
    • DOI 10.1023/B:PHAM.0000003390.51761.3d
    • Desilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20(11), 1885-1900 (2003). (Pubitemid 37449466)
    • (2003) Pharmaceutical Research , vol.20 , Issue.11 , pp. 1885-1900
    • Desilva, B.1    Smith, W.2    Weiner, R.3    Kelley, M.4    Smolec, J.5    Lee, B.6    Khan, M.7    Tacey, R.8    Hill, H.9    Celniker, A.10
  • 13
    • 0030575786 scopus 로고    scopus 로고
    • Critical issues in chiral drug analysis in biological fluids by high-performance liquid chromatography
    • DOI 10.1016/S0378-4347(96)00274-5, PII S0378434796002745
    • Ducharme J, Fernandez C, Gimenez F, Farinotti R. Critical issues in chiral drug analysis in biological fluids by high-performance liquid chromatography. J. Chromatogr. B Biomed. Appl. 686(1), 65-75 (1996). (Pubitemid 26382459)
    • (1996) Journal of Chromatography B: Biomedical Applications , vol.686 , Issue.1 , pp. 65-75
    • Ducharme, J.1    Fernandez, C.2    Gimenez, F.3    Farinotti, R.4
  • 14
    • 0036827348 scopus 로고    scopus 로고
    • Bioanalytical method validation and its implications for forensic and clinical toxicology - A review
    • DOI 10.1007/s00769-002-0516-5
    • Peters FT, Maurer H. Bioanalytical method validation and its implications for forensic and clinical toxicology - a review Accreditation Quality Assurance: J. Quality, Comparability Reliability Chem. Measurement 7(11), 441-449 (2002). (Pubitemid 36165305)
    • (2002) Accreditation and Quality Assurance , vol.7 , Issue.11 , pp. 441-449
    • Peters, F.T.1    Maurer, H.H.2
  • 15
    • 0030575807 scopus 로고    scopus 로고
    • Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics
    • DOI 10.1016/S0378-4347(96)00088-6, PII S0378434796000886
    • Bressolle F, Bromet-Petit M, Audran M. Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics. J. Chromatogr. B Biomed. Appl. 686(1), 3-10 (1996). (Pubitemid 26382452)
    • (1996) Journal of Chromatography B: Biomedical Applications , vol.686 , Issue.1 , pp. 3-10
    • Bressolle, F.1    Bromet-Petit, M.2    Audran, M.3
  • 18
    • 33644826088 scopus 로고    scopus 로고
    • Direct and fast determination of antiretroviral drugs by automated online solid-phase extraction-liquid chromatography-tandem mass spectrometry in human plasma
    • DOI 10.1515/CCLM.2006.052
    • Koal T, Sibum M, Koster E, Resch K, Kaever V. Direct and fast determination of antiretroviral drugs by automated online solid-phase extraction-liquid chromatography-tandem mass spectrometry in human plasma. Clin. Chem. Lab. Med. 44(3), 299-305 (2006). (Pubitemid 43357689)
    • (2006) Clinical Chemistry and Laboratory Medicine , vol.44 , Issue.3 , pp. 299-305
    • Koal, T.1    Sibum, M.2    Koster, E.3    Resch, K.4    Kaever, V.5
  • 19
    • 0025903573 scopus 로고
    • Validation of bioanalytical methods
    • Karnes HT, Shiu G, Shah VP. Validation of bioanalytical methods. Pharm. Res. 8(4), 421-426 (1991).
    • (1991) Pharm. Res. , vol.8 , Issue.4 , pp. 421-426
    • Karnes, H.T.1    Shiu, G.2    Shah, V.P.3
  • 20
    • 0031557167 scopus 로고    scopus 로고
    • Validation of chromatographic methods in biomedical analysis. Viewpoint and discussion
    • DOI 10.1016/S0378-4347(96)00297-6, PII S0378434796002976
    • Causon R. Validation of chromatographic methods in biomedical analysis. Viewpoint and discussion. J. Chromatogr. B Biomed. Sci. Appl. 689(1), 175-180 (1997). (Pubitemid 27089650)
    • (1997) Journal of Chromatography B: Biomedical Applications , vol.689 , Issue.1 , pp. 175-180
    • Causon, R.1
  • 21
    • 33646495061 scopus 로고    scopus 로고
    • Development and validation of a sensitive liquid chromatography/ electrospray tandem mass spectrometry assay for the quantification of olanzapine in human plasma
    • Nirogi RV, Kandikere VN, Shukla M et al. Development and validation of a sensitive liquid chromatography/electrospray tandem mass spectrometry assay for the quantification of olanzapine in human plasma. J. Pharm. Biomed. Anal. 41(3), 935-942 (2006).
    • (2006) J. Pharm. Biomed. Anal. , vol.41 , Issue.3 , pp. 935-942
    • Nirogi, R.V.1    Kandikere, V.N.2    Shukla, M.3
  • 22
    • 0031905797 scopus 로고    scopus 로고
    • A preliminary study on the stability of benzodiazepines in blood and plasma stored at 4°C
    • DOI 10.1007/s004140050100
    • Skopp G, Potsch L, Konig I, Mattern R. A preliminary study on the stability of benzodiazepines in blood and plasma stored at 4°C. Int. J. Legal Med. 111(1), 1-5 (1998). (Pubitemid 28105648)
    • (1998) International Journal of Legal Medicine , vol.111 , Issue.1 , pp. 1-5
    • Skopp, G.1    Potsch, L.2    Konig, I.3    Mattern, R.4
  • 25
    • 0019783181 scopus 로고
    • Stability of theophylline in serum, plasma, and saliva stored at different temperatures
    • Jonkman JH, Franke JP, Schoenmaker R, De Zeeuw RA. Stability of theophylline in serum, plasma, and saliva stored at different temperatures. Clin. Chem. 27(12), 2071-2072 (1981). (Pubitemid 12194447)
    • (1981) Clinical Chemistry , vol.27 , Issue.12 , pp. 2071-2072
    • Jonkman, J.H.G.1    Franke, J.P.2    Schoenmaker, R.3    De Zeeuw, R.A.4
  • 26
    • 0036007254 scopus 로고    scopus 로고
    • 9-carboxy-tetrahydrocannabinol glucuronide in plasma and urine assessed by liquid chromatography-tandem mass spectrometry
    • Skopp G, Potsch L. Stability of 11-nor-d(9)- carboxy-tetrahydrocannabinol glucuronide in plasma and urine assessed by liquid chromatography-tandem mass spectrometry. Clin. Chem. 48(2), 301-306 (2002). (Pubitemid 34107267)
    • (2002) Clinical Chemistry , vol.48 , Issue.2 , pp. 301-306
    • Skopp, G.1    Potsch, L.2
  • 27
    • 0026320469 scopus 로고
    • Stability of phencyclidine and amphetamines in urine specimens
    • Hughes R, Hughes A, Levine B, Smith Ml. Stability of phencyclidine and amphetamines in urine specimens. Clin. Chem. 37(12), 2141-2142 (1991). (Pubitemid 21925917)
    • (1991) Clinical Chemistry , vol.37 , Issue.12 , pp. 2141-2142
    • Hughes, R.1    Hughes, A.2    Levine, B.3    Smith, M.L.4
  • 28
    • 34547253837 scopus 로고    scopus 로고
    • Stability of analytes in biosamples-an important issue in clinical and forensic toxicology?
    • DOI 10.1007/s00216-007-1267-2, Analytical Toxicol
    • Peters FT. Stability of analytes in biosamples - an important issue in clinical and forensic toxicology? Anal. Bioanal. Chem. 388(7), 1505-1519 (2007). (Pubitemid 47150876)
    • (2007) Analytical and Bioanalytical Chemistry , vol.388 , Issue.7 , pp. 1505-1519
    • Peters, F.T.1
  • 29
    • 2942687251 scopus 로고    scopus 로고
    • Protocols for stability and homogeneity studies of drugs for its application to doping control
    • DOI 10.1016/j.aca.2004.03.045, PII S0003267004003599
    • Jiménez C, Ventura R, Segura J, De La Torrea R. Protocols for stability and homogeneity studies of drugs for its application to doping control Analytica Chimica Acta 515(2), 323-331 (2004). (Pubitemid 38781128)
    • (2004) Analytica Chimica Acta , vol.515 , Issue.2 , pp. 323-331
    • Jimenez, C.1    Ventura, R.2    Segura, J.3    De La Torre, R.4
  • 30
    • 33645092638 scopus 로고    scopus 로고
    • A new approach to evaluate stability of amodiaquine and its metabolite in blood and plasma
    • Blessborn D, Neamin G, Bergqvist Y, Lindegardh N. A new approach to evaluate stability of amodiaquine and its metabolite in blood and plasma. J. Pharm. Biomed. Anal. 41(1), 207-212 (2006).
    • (2006) J. Pharm. Biomed. Anal. , vol.41 , Issue.1 , pp. 207-212
    • Blessborn, D.1    Neamin, G.2    Bergqvist, Y.3    Lindegardh, N.4
  • 31
    • 0000888932 scopus 로고    scopus 로고
    • The study of the stability of reference materials by isochronous measurements
    • Lamberty A, Schimmel H, Pauwels J. The study of the stability of reference materials by isochronous measurements Fresenius J. Anal. Chem. 360(3-4), 359-361 (1998). (Pubitemid 128689010)
    • (1998) Fresenius' Journal of Analytical Chemistry , vol.360 , Issue.3-4 , pp. 359-361
    • Lamberty, A.1    Schimmel, H.2    Pauwels, J.3
  • 32
    • 27744437822 scopus 로고    scopus 로고
    • High-performance liquid chromatography-tandem mass spectrometry method for quantifying sulfonylurea herbicides in human urine: Reconsidering the validation process
    • DOI 10.1007/s00216-005-0099-1
    • Baker SE, Olsson AO, Needham LL, Barr DB. High-performance liquid chromatography-tandem mass spectrometry method for quantifying sulfonylurea herbicides in human urine: reconsidering the validation process. Anal. Bioanal. Chem. 383(6), 963-976 (2005). (Pubitemid 41618875)
    • (2005) Analytical and Bioanalytical Chemistry , vol.383 , Issue.6 , pp. 963-976
    • Baker, S.E.1    Olsson, A.O.2    Needham, L.L.3    Barr, D.B.4
  • 33
    • 0029930172 scopus 로고    scopus 로고
    • Rational experimental design for bioanalytical methods validation illustration using an assay method for total captopril in plasma
    • Wieling J, Hendriks G, Tamminga WJ et al. Rational experimental design for bioanalytical methods validation. Illustration using an assay method for total captopril in plasma. J. Chromatogr. A 730(1-2), 381-394 (1996).
    • (1996) J. Chromatogr. A , vol.730 , Issue.1-2 , pp. 381-394
    • Wieling, J.1    Hendriks, G.2    Tamminga, W.J.3


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