Proceedings from the workshop on science-based assessment accelerating product development of combination medical devices
| Autor Corporativo: | |
|---|---|
| Otros Autores: | |
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. :
The Academy
2004.
|
| Edición: | 1st ed |
| Materias: | |
| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622384806719 |
Tabla de Contenidos:
- ""Front Matter""; ""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 Mercy""""Science-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 Airplanes""""Bone 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 Institute""""DRUG-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""
