메뉴 건너뛰기




Volumn 9, Issue 3, 2007, Pages

Confirmatory reanalysis of incurred bioanalytical samples

Author keywords

Bioanalytical; ELISA; Immunoassay; Incurred samples; LC MS MS; Reproducibility

Indexed keywords

ACCURACY; ARTICLE; BIOASSAY; DATA ANALYSIS; DRUG SYNTHESIS; ENZYME LINKED IMMUNOSORBENT ASSAY; FOOD AND DRUG ADMINISTRATION; IMMUNOASSAY; LIQUID CHROMATOGRAPHY; MACROMOLECULE; MEDICAL SOCIETY; PATIENT SELECTION; QUALITY CONTROL; REPRODUCIBILITY; SAMPLE SIZE; STANDARD; TANDEM MASS SPECTROMETRY; TOXICITY TESTING; VALIDATION STUDY; WORKSHOP; METHODOLOGY; REVIEW; SENSITIVITY AND SPECIFICITY;

EID: 38849144763     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/aapsj0903040     Document Type: Article
Times cited : (134)

References (14)
  • 1
    • 84988175795 scopus 로고
    • Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies
    • Shah DD, Midha KK, Dighe SV, et al. Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci. 1992;81:309-312.
    • (1992) J Pharm Sci , vol.81 , pp. 309-312
    • Shah, D.D.1    Midha, K.K.2    Dighe, S.V.3
  • 2
    • 33847397009 scopus 로고    scopus 로고
    • The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation
    • Shah VP. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS J. 2007;9:E43-E47.
    • (2007) AAPS J , vol.9
    • Shah, V.P.1
  • 3
    • 33847184252 scopus 로고    scopus 로고
    • 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. 2007;9:E30-E42.
    • 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. 2007;9:E30-E42.
  • 4
    • 0033989957 scopus 로고    scopus 로고
    • Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective
    • Findlay JWA, Smith WC, Lee JW, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21:1249-1273.
    • (2000) J Pharm Biomed Anal , vol.21 , pp. 1249-1273
    • Findlay, J.W.A.1    Smith, W.C.2    Lee, J.W.3
  • 5
    • 0003484310 scopus 로고    scopus 로고
    • FDA/CDER, Rockville, MD: US Department of Health and Human Services FDA (CDER) and CVM, May
    • FDA/CDER. Guidance for the Industry. Bioanalytical Method Validation. Rockville, MD: US Department of Health and Human Services FDA (CDER) and (CVM); May 2001.
    • (2001) Guidance for the Industry. Bioanalytical Method Validation
  • 6
    • 10744230729 scopus 로고    scopus 로고
    • Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
    • 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. 2003;20:1885-1900.
    • (2003) Pharm Res , vol.20 , pp. 1885-1900
    • DeSilva, B.1    Smith, W.2    Weiner, R.3
  • 10
    • 44949152872 scopus 로고    scopus 로고
    • Canadian Health Ministry, Available at:, Accessed September 27, 2007
    • Canadian Health Ministry. Notice to Industry - Removal of Requirement for 15% Random Replicate Samples. 2003; Available at: http://he-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide--ld/bio/ 15rep_p.html. Accessed September 27, 2007.
    • (2003) Notice to Industry - Removal of Requirement for 15% Random Replicate Samples
  • 11
    • 84908219488 scopus 로고
    • Statistical methods for assessing agreement between two methods of clinical measurement
    • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;i:307-310.
    • (1986) Lancet , vol.1 , pp. 307-310
    • Bland, J.M.1    Altman, D.G.2
  • 12
    • 0025048927 scopus 로고
    • A note on the use of intraclass correlation coefficient in the evaluation of agreement between two methods of measurement
    • Bland JM, Altman DG. A note on the use of intraclass correlation coefficient in the evaluation of agreement between two methods of measurement. Comput Biol Med. 1990;20:337-340.
    • (1990) Comput Biol Med , vol.20 , pp. 337-340
    • Bland, J.M.1    Altman, D.G.2
  • 13
    • 33646272448 scopus 로고    scopus 로고
    • The minimum significant ratio: A statistical parameter to characterize the reproducibility of potency estimates from concentration-response assays and estimation by replicate-experiment studies
    • Eastwood BJ, Farmen MW, Iversen PW, et al. The minimum significant ratio: a statistical parameter to characterize the reproducibility of potency estimates from concentration-response assays and estimation by replicate-experiment studies. J Biomol Screen. 2006;11:253-261.
    • (2006) J Biomol Screen , vol.11 , pp. 253-261
    • Eastwood, B.J.1    Farmen, M.W.2    Iversen, P.W.3
  • 14
    • 44949107678 scopus 로고    scopus 로고
    • and Company and the National Institutes of Health (NIH) Chemical Genomics Center NCGC, Available at:, Accessed September 27, 2007
    • Eli Lilly and Company and the National Institutes of Health (NIH) Chemical Genomics Center (NCGC). Transfer of validated assays, 2005. Available at: http://www.ncgc.nih.gov/guidance/ section2.html#analysis-potency. Accessed September 27, 2007.
    • (2005) Transfer of validated assays
    • Lilly, E.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.