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Volumn 7, Issue 2, 2005, Pages

Challenges in the transition to model-based development

Author keywords

Model based development; Pharmacometrics; Real time data assembly

Indexed keywords

ARTICLE; ATTITUDE TO CHANGE; CULTURAL FACTOR; DATA ANALYSIS; DECISION MAKING; DRUG RESEARCH; HUMAN; INFORMATION PROCESSING; ORGANIZATION; PERFORMANCE; PERSONNEL MANAGEMENT; PRACTICE GUIDELINE; PROCESS DESIGN; PROCESS DEVELOPMENT; PROCESS MODEL; SIMULATION; STAFF TRAINING; TEAMWORK;

EID: 30444434228     PISSN: 15221059     EISSN: 15221059     Source Type: Journal    
DOI: 10.1208/aapsj070249     Document Type: Article
Times cited : (20)

References (10)
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    • Learning versus confirming in clinical drug development
    • Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther. 1997;61:275-291.
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    • Sheiner, L.B.1
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    • note
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  • 6
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    • An evaluation of population pharmacokinetics in therapeutic trials Part III. Prospective data collection versus retrospective data assembly
    • Antal EJ, Grasela TH Jr, Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part III. Prospective data collection versus retrospective data assembly. Clin Pharmacol Ther. 1989;46:552-559.
    • (1989) Clin Pharmacol Ther. , vol.46 , pp. 552-559
    • Antal, E.J.1    Grasela Jr., T.H.2    Smith, R.B.3
  • 7
    • 0031047868 scopus 로고    scopus 로고
    • Prospective use of population pharmacokinetics/pharmacodynamics in the development of cisatracurium
    • Schmith VD, Fiedler-Kelly J, Phillips L, Grasela TH Jr. Prospective use of population pharmacokinetics/pharmacodynamics in the development of cisatracurium. Pharm Res. 1997;14:91-97.
    • (1997) Pharm Res. , vol.14 , pp. 91-97
    • Schmith, V.D.1    Fiedler-Kelly, J.2    Phillips, L.3    Grasela Jr., T.H.4
  • 8
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    • An automated drug concentration screening and quality assurance program for clinical trials
    • Grasela TH, Antal EJ, Fiedler-Kelly J, et al. An automated drug concentration screening and quality assurance program for clinical trials. Drug Inf J. 1999;33:273-279.
    • (1999) Drug Inf J. , vol.33 , pp. 273-279
    • Grasela, T.H.1    Antal, E.J.2    Fiedler-Kelly, J.3
  • 9
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    • FDA. Guidance for Industry: Washington, DC: Food and Drug Administration
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    • (1999) Population Pharmacokinetics


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.