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.
- Washington, DC : National Academy Press, �1999.
- 1 online resource (xii, 76 pages) : illustrations.
- The compass series .
- Compass series (Washington, D.C.) .
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.
English.
0585142610 9780585142616 030952024X 9780309520249
00500867
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.
Electronic books. Congress. Conference papers and proceedings. Electronic books.