|
|
|
|
|
|
|
|
1. |
Record Nr. |
UNINA9910778746103321 |
|
|
Titolo |
Assuring data quality and validity in clinical trials for regulatory decision making [[electronic resource] ] : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors |
|
|
|
|
|
|
|
Pubbl/distr/stampa |
|
|
Washington, DC, : National Academy Press, c1999 |
|
|
|
|
|
|
|
ISBN |
|
0-309-17280-2 |
0-309-52024-X |
0-585-14261-0 |
|
|
|
|
|
|
|
|
Descrizione fisica |
|
1 online resource (88 p.) |
|
|
|
|
|
|
Collana |
|
|
|
|
|
|
Altri autori (Persone) |
|
|
|
|
|
|
Disciplina |
|
|
|
|
|
|
Soggetti |
|
Clinical trials - Quality control |
|
|
|
|
|
|
Lingua di pubblicazione |
|
|
|
|
|
|
Formato |
Materiale a stampa |
|
|
|
|
|
Livello bibliografico |
Monografia |
|
|
|
|
|
Note generali |
|
Description based upon print version of record. |
|
|
|
|
|
|
Nota di bibliografia |
|
Includes bibliographical references (p. 75-76). |
|
|
|
|
|
|
Nota di contenuto |
|
Front Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and Acronyms |
|
|
|
|
|
|
|