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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.

ISBN: 0585142610 9780585142616 030952024X 9780309520249

LCCN: 00500867

Subjects--Corporate Names:
United States. Food and Drug Administration.
United States. Food and Drug Administration.
United States. Food and Drug Administration.

Subjects--Topical Terms:
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.

Subjects--Index Terms: Andre fag (naturvidenskab og teknik) Andre fag.

Index Terms--Genre/Form:
Electronic books.
Congress.
Conference papers and proceedings.
Electronic books.

LC Class. No.: R853.C55 / A876 1999eb

Dewey Class. No.: 610.28

National Library of Medicine Call No.: QV 771 / A851 1999