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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making : Workshop Report.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine Staff (Autor)
Otros Autores: Davis, Jonathan R. (Editor ), Nolan, Vivian P. (Editor ), Woodcock, Janet (Editor ), Estabrook, Ronald W. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, July 1999.
Colección:Compass series (Washington, D.C.)
Temas:
Acceso en línea:Texto completo
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.