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Volumn , Issue , 2009, Pages 265-286

Strategies for Successful Transfer of Ligand-Binding Assays for Successful Validation and Implementation in GXP Environment

Author keywords

Ligand binding assay transfer for validation and implementation in GXP environment; Monitoring method transfer process; Successful working relationships between laboratories

Indexed keywords


EID: 79951895464     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470541517.ch10     Document Type: Chapter
Times cited : (3)

References (9)
  • 1
    • 0003484310 scopus 로고    scopus 로고
    • Guidance for Industry: Bioanalytical Method Validation. U.S. Department of Health and Human Services
    • Food and Drug Administration, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD
    • Food and Drug Administration (2001) Guidance for Industry: Bioanalytical Method Validation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD.
    • (2001)
  • 3
    • 84889497078 scopus 로고    scopus 로고
    • International Society of Pharmaceutical Engineers Good Practice Guide
    • Technology Transfer
    • International Society of Pharmaceutical Engineers Good Practice Guide: Technology Transfer, 2003.
    • (2003)
  • 5
    • 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., Kelley, M., Smolec, J., Lee, B., Kahn, M., Tacey, R., Hill, H., and Celniker, A., (2003) Recommendations for the bioanalytical method validation of ligand binding assays to support pharmacokinetic assessments of macromolecules. Pharmaceutical Research, 20, 1885-1900.
    • (2003) Pharmaceutical Research , vol.20 , pp. 1885-1900
    • DeSilva, B.1    Smith, W.2    Weiner, R.3    Kelley, M.4    Smolec, J.5    Lee, B.6    Kahn, M.7    Tacey, R.8    Hill, H.9    Celniker, A.10
  • 8
    • 0000037284 scopus 로고
    • Reappraisal of hypothesis testing for method validation: detection of systematic error by comparing the means of two methods or two laboratories
    • Hartmann, C., Smeyers-Verbeke, J., Penninckx, W., Heyden, Y.V., Vankeerberghen, P., and Massart, D.L. , (1995) Reappraisal of hypothesis testing for method validation: detection of systematic error by comparing the means of two methods or two laboratories. Analytical Chemistry, 67, 4491-4499.
    • (1995) Analytical Chemistry , vol.67 , pp. 4491-4499
    • Hartmann, C.1    Smeyers-Verbeke, J.2    Penninckx, W.3    Heyden, Y.V.4    Vankeerberghen, P.5    Massart, D.L.6
  • 9
    • 0003973026 scopus 로고    scopus 로고
    • Immunoassay: A Practical Guide
    • Taylor & Francis, London
    • Law, B. (ed.) (1996) Immunoassay: A Practical Guide. Taylor & Francis, London.
    • (1996)
    • Law, B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.