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

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

Detalles Bibliográficos
Autor Corporativo: Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices (-)
Otros Autores: Davis, Jonathan R. (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, DC : National Academy Press c1999.
Edición:1st ed
Colección:Compass series (Washington, D.C.)
Materias:
United States. > Food and Drug Administration.
Clinical trials > Quality control.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820327306719
Tabla de Contenidos:
  • 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

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