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Proceedings from the Workshop on Science-Based Assessment : Accelerating Product Development of Combination Medical Devices /
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Autor Corporativo: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
[Place of publication not identified] :
National Academies Press
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- FrontMatter
- Preface
- Contents
- ABSTRACTS
- Setting the Context
- USE OF SCIENCE-BASED ASSESSMENT IN THE DEVELOPMENT OF STANDARDS John T. Watson National Heart, Lung, and Blood Institute National Institutes of Health
- SETTING THE CONTEXT: CLINICIAN Renu Virmani Department of Cardiovascular Pathology Armed Forces Institute of Pathology
- SCIENCE-BASED TESTING: BALANCING RISK AND REWARD Paul Citron Medtronic, Inc.
- BIOFILMS AND MEDICAL DEVICES William Costerton Center for Biofilm Engineering Montana State University
- TESTING FOR SAFETY AND EFFICACY: AN ETHICIST�S PERSPECTIVE Leonard J. Weber University of Detroit MercyScience-Based Assessment and Experimental Design
- SCIENCE-BASED TESTING FOR COMBINATION DEVICES Aric Kaiser Center for Devices and Radiological Health U.S. Food and Drug Administration
- SCIENCE-BASED TESTING FOR BIOLOGICS Darin J. Weber Center for Biologics Evaluation and Research U.S. Food and Drug Administration
- USING DESIGN OF EXPERIMENT METHODS IN THE INNOVATION PROCESS James Rutledge DataVision Statistical Consulting and Training, LLC
- MAKING IT FLY: CURRENT BOEING CERTIFICATION PROCESSES Stephen G. LaRiviere Boeing Commercial AirplanesBone Morphogenetic Proteins and Orthopedic Repair
- THE BASIC SCIENCE OF BONE MORPHOGENETIC PROTEINS AND THE IMPORTANCE OF TEST METHODS Barbara D. Boyan Georgia Institute of Technology
- BONE MORPHOGENETIC PROTEIN COMBINATION PRODUCTS AND ORTHOPEDIC REPAIR Amy J. LaForte Stryker Biotech
- PRODUCT DEVELOPMENT PROCESS FOR A BONE MORPHOGENETIC PROTEIN COMBINATION PRODUCT William McKay Medtronic Sofamor Danek
- Drug-Eluting Stents
- DRUG-ELUTING STENTS: CURRENT CLINICAL STATUS Robert S. Schwartz Minneapolis Heart InstituteDRUG-ELUTING STENTS: PRECLINICAL TESTING CHALLENGES H. Semih Oktay CardioMed Device Consultants, LLC
- TAXUS: A POLYMER-BASED PACLITAXEL-ELUTING STENT Ronald A. Sahatjian Boston Scientific Corporation
- Cell-Matrix Cartilage Implants
- CELL-MATRIX CARTILAGE IMPLANTS: A CLINICIAN�S PERSPECTIVE Richard D. Coutts University of California at San Diego
- CELL THERAPY FOR CARTILAGE REPAIR: PRESENT AND FUTURE James W. Burns Genzyme
- CELL-MATRIX CARTILAGE IMPLANTS FOR ARTICULAR REPAIR AND REPLACEMENT Anthony Ratcliffe Synthasome, Inc.APPENDIXES
- APPENDIX A WORKSHOP AGENDA
- APPENDIX B BIOGRAPHIES OF SPEAKERS AND SESSION CHAIRS