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E-BOOK
Title 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.
Imprint Washington, DC : National Academy Press, ©1999.

Copies/Volumes

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 Internet  Electronic Book    AVAILABLE
Description 1 online resource (xii, 76 pages) : illustrations.
Series The compass series
Compass series (Washington, D.C.)
Bibliog. Includes bibliographical references (pages 75-76).
Note Available only to authorized UTEP users.
English.
Print version record.
Subject United States. Food and Drug Administration.
United States. Food and Drug Administration.
Clinical trials -- Quality control.
Clinical trials -- Data processing -- Congresses.
United States Food and Drug Administration.
Clinical Trials -- standards -- Congresses.
Decision Making -- Congresses.
Quality Control -- Congresses.
Research Design -- Congresses.
Genre Electronic books.
Congress.
Conference papers and proceedings.
Contents Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices.
Other Author Davis, Jonathan R.
Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.
Other Title Print version: Assuring data quality and validity in clinical trials for regulatory decision making. Washington, DC : National Academy Press, ©1999 0309065941