Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors.
Material type:
TextSeries: Compass series (Washington, D.C.)Publication details: Washington, DC : National Academy Press, �1999.Description: 1 online resource (xii, 76 pages) : illustrationsContent type: - text
- computer
- online resource
- 0585142610
- 9780585142616
- 030952024X
- 9780309520249
- United States. Food and Drug Administration
- United States. Food and Drug Administration
- United States. Food and Drug Administration
- Clinical trials -- Quality control
- Clinical trials -- Data processing -- Congresses
- MEDICAL -- Drug Guides
- MEDICAL -- Nursing -- Pharmacology
- MEDICAL -- Pharmacology
- MEDICAL -- Pharmacy
- Clinical trials -- Data processing
- United States Food and Drug Administration
- Clinical Trials -- standards -- Congresses
- Decision Making -- Congresses
- Quality Control -- Congresses
- Research Design -- Congresses
- Andre fag (naturvidenskab og teknik) Andre fag
- 610.28 21
- R853.C55 A876 1999eb
- QV 771
Includes bibliographical references (pages 75-76).
Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices.
Print version record.
English.
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