메뉴 건너뛰기




Volumn 6, Issue 2, 2006, Pages 82-88

Retrospective validation of genomic biomarkers - What are the questions, challenges and strategies for developing useful relationships to clinical outcomes - Workshop summary

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; DNA; ERLOTINIB; NEW DRUG;

EID: 33645061021     PISSN: 1470269X     EISSN: 14731150     Source Type: Journal    
DOI: 10.1038/sj.tpj.6500363     Document Type: Conference Paper
Times cited : (22)

References (9)
  • 1
    • 2542641907 scopus 로고    scopus 로고
    • 'Innovation and Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products'
    • FDA white paper Issued March 16
    • McClellan M. FDA white paper 'Innovation and Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products', Issued March 16, 2004. http://www.fda.gov.
    • (2004)
    • McClellan, M.1
  • 2
    • 33645092768 scopus 로고    scopus 로고
    • Tarceva (erlotinib) Labelling Package Insert Website
    • Tarceva (erlotinib) Labelling Package Insert 2004. Website http://www.tarceva.com/tarceva/patient/PI.jsp.
    • (2004)
  • 3
    • 33645067766 scopus 로고    scopus 로고
    • Code of Federal Regulations (CFR). Title 21, Section 314.126, adequate and well-controlled studies, applications for FDA approval to market a new drug. Website
    • Code of Federal Regulations (CFR). Title 21, Section 314.126, adequate and well-controlled studies, applications for FDA approval to market a new drug. Website: http://www.convergentcosmetics.com/virtual_lab/ resources/CFR_21_Parts_1_to_799.htm.
  • 4
    • 14044267086 scopus 로고    scopus 로고
    • 'Providing clinical evidence of effectiveness for human drug and biological products'
    • Guidance for Industry. (May)
    • Guidance for Industry. 'Providing clinical evidence of effectiveness for human drug and biological products' (May, 1998). http://www.fda.gov/cder/ guidance/1397fnl.pdf.
    • (1998)
  • 5
    • 33645080538 scopus 로고    scopus 로고
    • International Conference on Harmonization. Statistical Principles for Clinical Trials (ICH E-9), US Food and Drug Administration, DHHS, February
    • International Conference on Harmonization. Statistical Principles for Clinical Trials (ICH E-9), US Food and Drug Administration, DHHS, February 1998.
    • (1998)
  • 6
    • 0037380651 scopus 로고    scopus 로고
    • Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PWG-PhRMA-DruSafe Workshop
    • Lesko LJ, Salerno RA, Spear B, Anderson DC, Brazell C, Collins J et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PWG-PhRMA-DruSafe Workshop. J Clin Pharmacol 2003; 43: 342-358.
    • (2003) J Clin Pharmacol , vol.43 , pp. 342-358
    • Lesko, L.J.1    Salerno, R.A.2    Spear, B.3    Anderson, D.C.4    Brazell, C.5    Collins, J.6
  • 7
    • 33645046499 scopus 로고    scopus 로고
    • Guidance for Industry. Pharmacogenomic Data Submission Website
    • Guidance for Industry. Pharmacogenomic Data Submission (2005). Website: http://www.fda.gov/cder/genomics/regulatory.htm.
    • (2005)
  • 8
    • 33645050515 scopus 로고    scopus 로고
    • Pharmacogenomic data submissions to FDA: Clinical pharmacology case studies. Special report 4 of pharmacogenomic data: FDA voluntary and required submission guidance
    • Ruano G, Collins JM, Dorner AJ, Wang SJ, Guerciolini R, Huang SM. Pharmacogenomic data submissions to FDA: Clinical pharmacology case studies. Special report 4 of pharmacogenomic data: FDA voluntary and required submission guidance. Pharmacogenomics 2004; 5: 513-517.
    • (2004) Pharmacogenomics , vol.5 , pp. 513-517
    • Ruano, G.1    Collins, J.M.2    Dorner, A.J.3    Wang, S.J.4    Guerciolini, R.5    Huang, S.M.6
  • 9
    • 33645076132 scopus 로고    scopus 로고
    • Pharmacogenomic data submissions to FDA: Clinical case studies. Special report 5 of pharmacogenomic data: FDA voluntary and required submission guidance
    • Trepicchio WL, Williams GA, Essayan D, Hall ST, Harty LC, Shaw PM et al. Pharmacogenomic data submissions to FDA: Clinical case studies. Special report 5 of pharmacogenomic data: FDA voluntary and required submission guidance. Pharmacogenomics 2004; 5: 519-524.
    • (2004) Pharmacogenomics , vol.5 , pp. 519-524
    • Trepicchio, W.L.1    Williams, G.A.2    Essayan, D.3    Hall, S.T.4    Harty, L.C.5    Shaw, P.M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.