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Proceedings from the Workshop on Science-Based Assessment : Accelerating Product Development of Combination Medical Devices /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Scarborough, Bonnie A.
Autor Corporativo: Roundtable on Biomedical Engineering Materials and Applications, National Research Council
Otros Autores: Scarborough, Bonnie A.(CB)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: [Place of publication not identified] : National Academies Press
Temas:
Acceso en línea:Texto completo

MARC

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505 0 |a 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 
505 8 |a TESTING FOR SAFETY AND EFFICACY: AN ETHICISTâ€?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 
505 8 |a 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 
505 8 |a 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 CLINICIANâ€?S PERSPECTIVE Richard D. Coutts University of California at San Diego -- CELL THERAPY FOR CARTILAGE REPAIR: PRESENT AND FUTURE James W. Burns Genzyme 
505 8 |a 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 
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