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Volumn 7, Issue 2, 2010, Pages 167-173

Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development

Author keywords

[No Author keywords available]

Indexed keywords

ADAPTATION; CHANGE MANAGEMENT; DECISION MAKING; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; HEALTH SURVEY; PHARMACEUTICS; PRIORITY JOURNAL; QUANTITATIVE STUDY; REVIEW; ARTICLE; CLINICAL TRIAL; DRUG INDUSTRY; HEALTH CARE ORGANIZATION; HUMAN; METHODOLOGY; ORGANIZATION AND MANAGEMENT; RISK ASSESSMENT;

EID: 77953666447     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774510361542     Document Type: Review
Times cited : (48)

References (13)
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  • 2
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    • Adaptivity in drug discovery and development
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    • Bretz, F.1    Branson, M.2    Burman, C.F.3
  • 3
    • 33646245937 scopus 로고    scopus 로고
    • Executive summary of the PhRMA working group on adaptive designs in clinical drug development
    • Gallo P, Chuang-Stein C, Dragalin V, et al. Executive summary of the PhRMA working group on adaptive designs in clinical drug development. J Biopharm Stat 2006; 16: 275-83.
    • (2006) J Biopharm Stat , vol.16 , pp. 275-83
    • Gallo, P.1    Chuang-Stein, C.2    Dragalin, V.3
  • 4
    • 33750856587 scopus 로고    scopus 로고
    • PhRMA working group on adaptive designs: Introduction to the full white paper
    • Gallo P, Krams M. PhRMA working group on adaptive designs: introduction to the full white paper. Drug Info J 2006; 40: 421-3.
    • (2006) Drug Info J , vol.40 , pp. 421-3
    • Gallo, P.1    Krams, M.2
  • 5
    • 33750893179 scopus 로고    scopus 로고
    • Implementing adaptive designs: Logistical and operational considerations
    • Quinlan JA, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Info J 2006; 40: 437-44.
    • (2006) Drug Info J , vol.40 , pp. 437-44
    • Quinlan, J.A.1    Krams, M.2
  • 6
    • 72149125591 scopus 로고    scopus 로고
    • Planning and executing response-adaptive learn-phase clinical trials: 1. Theprocess
    • Fardipour P, Littman G, Burns D, et al. Planning and executing response-adaptive learn-phase clinical trials: 1. Theprocess. Drug Info J 2009; 43: 713-23.
    • (2009) Drug Info J , vol.43 , pp. 713-23
    • Fardipour, P.1    Littman, G.2    Burns, D.3
  • 7
    • 70350139975 scopus 로고    scopus 로고
    • Good practices for adaptive clinical trials in pharmaceutical product development
    • Gaydos B, Anderson K, Berry DA, et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Info J 2009; 43: 539-56.
    • (2009) Drug Info J , vol.43 , pp. 539-56
    • Gaydos, B.1    Anderson, K.2    Berry, D.A.3
  • 8
    • 33750884934 scopus 로고    scopus 로고
    • Confidentiality and trial integrity issues for adaptive designs
    • Gallo P. Confidentiality and trial integrity issues for adaptive designs. Drug Info J 2006; 40: 445-50.
    • (2006) Drug Info J , vol.40 , pp. 445-50
    • Gallo, P.1
  • 10
    • 55549107541 scopus 로고    scopus 로고
    • Designing, monitoring, and modifying an adaptive trial
    • Dragalin V. Designing, monitoring, and modifying an adaptive trial. Am Pharm Outsourc 2008; 9: 12-16.
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    • Dragalin, V.1
  • 11
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    • Global harmo-nization of standards for adaptive clinical trial designs
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  • 12
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    • Interactions with regulatory agencies to enhance the understanding and acceptance of adaptive designs
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  • 13
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    • Available at accessed 20 December 2009
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    • Dick Clark in An Interview with the Financial Times 2006


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.