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150223 r ||| eng |
| 020 |
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|a 9780309065948
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| 020 |
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|a 0309065941
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| 100 |
1 |
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|a Davis, Jonathan R.
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| 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
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| 260 |
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|a Washington, DC
|b National Academy Press
|c 1999, c1999
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| 300 |
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|a xii, 76 p.
|b ill.
|c 23 cm
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| 505 |
0 |
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|a Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices
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| 505 |
0 |
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|a Includes bibliographical references
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| 653 |
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|a Research Design
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| 653 |
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|a Decision Making
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| 653 |
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|a Quality Control
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| 653 |
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|a Clinical Trials as Topic / standards
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| 710 |
2 |
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|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
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| 989 |
|
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|b NCBI
|a National Center for Biotechnology Information
|
| 856 |
4 |
0 |
|u http://books.nap.edu/catalog/9623.html
|3 Volltext
|n Provider site
|3 Volltext
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| 856 |
4 |
0 |
|u https://www.ncbi.nlm.nih.gov/books/NBK224577
|3 Volltext
|n NLM Bookshelf Books
|3 Volltext
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| 082 |
0 |
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|a 610
|