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Volumn 86, Issue 1, 2009, Pages 26-27

Biomarkers in clinical drug development

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; ANTIVIRUS AGENT; ARGATROBAN; BIOLOGICAL MARKER; BUSULFAN; CARVEDILOL; CREATININE; CYCLOSPORIN; GLUCOSE; PIPERACILLIN; PROSTATE SPECIFIC ANTIGEN; RISEDRONIC ACID; SOTALOL; TAZOBACTAM; WARFARIN; ZOLEDRONIC ACID;

EID: 67650624058     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.57     Document Type: Note
Times cited : (25)

References (9)
  • 1
    • 67650604373 scopus 로고    scopus 로고
    • The value, qualification, and regulatory use of surrogate end points in drug development
    • Lathia CD et al. The value, qualification, and regulatory use of surrogate end points in drug development. Clin. Pharmacol. Ther. 86, 32-43.
    • Clin. Pharmacol. Ther , vol.86 , pp. 32-43
    • Lathia, C.D.1
  • 2
    • 67650636515 scopus 로고    scopus 로고
    • US Food and Drug Administration. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 1998).
    • US Food and Drug Administration. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 1998).
  • 3
    • 0037534027 scopus 로고    scopus 로고
    • Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval
    • Peck, C.C., Rubin, D.B. & Sheiner, L.B. Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin. Pharmacol. Ther. 73, 481-490 (2003).
    • (2003) Clin. Pharmacol. Ther , vol.73 , pp. 481-490
    • Peck, C.C.1    Rubin, D.B.2    Sheiner, L.B.3
  • 4
    • 0035037328 scopus 로고    scopus 로고
    • Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
    • Lesko, L.J. & Atkinson, A.J. Jr. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu. Rev. Pharmacol. Toxicol. 41, 347-366 (2001).
    • (2001) Annu. Rev. Pharmacol. Toxicol , vol.41 , pp. 347-366
    • Lesko, L.J.1    Atkinson Jr., A.J.2
  • 5
    • 38349115335 scopus 로고    scopus 로고
    • Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006
    • Wang, Y. et al. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. J. Clin. Pharmacol. 48, 146-156 (2008).
    • (2008) J. Clin. Pharmacol , vol.48 , pp. 146-156
    • Wang, Y.1
  • 6
    • 67650590069 scopus 로고    scopus 로고
    • Actonel product label. Cincinnati, OH: Procter & Gamble.
    • Actonel product label. Cincinnati, OH: Procter & Gamble.
  • 7
    • 67650634070 scopus 로고    scopus 로고
    • Carvedilol product label. Philadelphia, PA: GlaxoSmithKline
    • Carvedilol product label. Philadelphia, PA: GlaxoSmithKline.
  • 8
    • 67650634071 scopus 로고    scopus 로고
    • Zosyn product label. Philadelphia, PA: Wyeth
    • Zosyn product label. Philadelphia, PA: Wyeth.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.