Assuring data quality and validity in clinical trials for regulatory decision making : workshop report

Main Author: Davis, Jonathan R.
Corporate Author: Institute of Medicine (U.S.) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Format: eBook
Language:English
Published: Washington, DC National Academy Press 1999, c1999
Subjects:
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
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100 1 |a Davis, Jonathan R. 
245 0 0 |a Assuring data quality and validity in clinical trials for regulatory decision making  |h Elektronische Ressource  |b workshop report  |c Roundtable on Research and Development of Drugs, Biologics, and Medical Devices ; Jonathan R. Davis ... [et al.], editors 
260 |a Washington, DC  |b National Academy Press  |c 1999, c1999 
300 |a xii, 76 p.  |b ill.  |c 23 cm 
505 0 |a Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices 
505 0 |a Includes bibliographical references 
653 |a Research Design 
653 |a Decision Making 
653 |a Quality Control 
653 |a Clinical Trials as Topic / standards 
710 2 |a Institute of Medicine (U.S.)  |b Roundtable on Research and Development of Drugs, Biologics, and Medical Devices 
041 0 7 |a eng  |2 ISO 639-2 
989 |b NCBI  |a National Center for Biotechnology Information 
856 |u http://books.nap.edu/catalog/9623.html  |3 Volltext 
856 |u https://www.ncbi.nlm.nih.gov/books/NBK224577  |3 Volltext 
082 0 |a 610