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Volumn 59, Issue 23, 2002, Pages

Understanding and preparing for clinical drug trial audits

Author keywords

[No Author keywords available]

Indexed keywords

BIOAVAILABILITY; CLINICAL PRACTICE; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; MEDICAL AUDIT; MEDICAL RECORD; MEDICAL RESEARCH; NOTE; PRIORITY JOURNAL; QUALITY CONTROL;

EID: 0036995805     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.1093/ajhp/59.23.2301     Document Type: Note
Times cited : (4)

References (11)
  • 2
    • 0001184885 scopus 로고    scopus 로고
    • International Conference on Harmonization; Good clinical practice consolidated guidelines
    • Food and Drug Administration. International Conference on Harmonization; Good Clinical Practice consolidated guidelines. Fed Regist. 1997;62:25692-709.
    • (1997) Fed Regist , vol.62 , pp. 25692-25709
  • 3
  • 4
    • 0013278545 scopus 로고    scopus 로고
    • Anticipating an audit
    • Ginsberg D, ed. Boston: CenterWatch, Inc.
    • Anticipating an audit. In: Ginsberg D, ed. The investigator's guide to clinical research. 2nd ed. Boston: CenterWatch, Inc.; 1999:153-6.
    • (1999) The Investigator's Guide to Clinical Research. 2nd Ed. , pp. 153-156
  • 5
    • 0013317942 scopus 로고
    • FDA inspections
    • Iber FL, Riley WA, Murray PJ, eds. New York: Plenum Medical
    • FDA inspections. In: Iber FL, Riley WA, Murray PJ, eds. Conducting clinical trials. New York: Plenum Medical; 1987:315-23.
    • (1987) Conducting Clinical Trials , pp. 315-323
  • 6
    • 0033004876 scopus 로고    scopus 로고
    • Preparing a clinical site for a clinical investigator inspection by the FDA
    • Curran CF. Preparing a clinical site for a clinical investigator inspection by the FDA. Drug Inf J. 1999; 33:253-6.
    • (1999) Drug Inf J , vol.33 , pp. 253-256
    • Curran, C.F.1
  • 7
    • 0013275183 scopus 로고    scopus 로고
    • 21 C.F.R. 312.59
    • 21 C.F.R. 312.59.
  • 8
    • 0013229535 scopus 로고    scopus 로고
    • 21 C.F.R. 312.61
    • 21 C.F.R. 312.61.
  • 9
    • 0013228753 scopus 로고    scopus 로고
    • 21 C.F.R. 312.62
    • 21 C.F.R. 312.62.
  • 10
    • 0013226458 scopus 로고    scopus 로고
    • Guidelines on clinical drug research
    • Deffenbaugh JH, ed. Bethesda, MD: American Society of Health-System Pharmacists
    • Guidelines on clinical drug research. In: Deffenbaugh JH, ed. Best practices for health-system pharmacy: position and guidance documents of ASHP 2001-2002. Bethesda, MD: American Society of Health-System Pharmacists; 2002:294-300.
    • (2002) Best Practices for Health-system Pharmacy: Position and Guidance Documents of ASHP 2001-2002 , pp. 294-300
  • 11
    • 0013229187 scopus 로고    scopus 로고
    • Compliance program guidance
    • Food and Drug Administration. Compliance program guidance. Manual for FDA staff. Part III - inspectional. www.fda.gov/ora/compliance_ref/bimo/7348_811 (accessed 2002 May 5).
    • Manual for FDA Staff. Part III - Inspectional


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.