This book will present contributions by economists, systems developers, safety, health services, occupational and environmental health, and biomedical researchers in the fields of regulatory development, safety, quality assurance, health outcomes, occupational health, and biomedicine. The contributing research will explore the synergy of new science-based risk regulatory approaches, industry focus on manufacturing efficiencies and information technology and biogenetic innovations, and consumers demand for improved safety and quality of products, services, quality assurance, and transparency of information.The book investigates the impact of information technology, biogenetic, and pharmacological innovation on individuals quality of life, safety, individual and system health care utilization, occupational and environmental health and formulary decision making, and costs. It contains analyses of clinical and health outcomes resulting from innovative biopharmaceutical entities and delivery systems in the treatment of chronic conditions.It emphasises effective quality, regulatory system, and consistent science-based decision-making practices from private and public organizations and demonstrates regulatory issues affecting innovation and efficiency.
Contents: Introduction (I. Farquhar, K. Summers, A. Sorkin). INNOVATION IN REGULATORY AND OUTCOMES RESEARCH APPLICATIONS (1) After-Market Drug Regulation: Promoting Public Trust in Innovation (R. Field); (2) Transcending Tradition: Quality of Life as the Inextricable Link Between Activities of Daily Living and Specific Organ and Disease States (E. Vinik and A. Vinik); (3) Development and Validation of Eleven Symptom Indices to Evaluate Response to Chemotherapy for Advanced Cancer: Measurement Compliance with Regulatory Demands (S. Rosenbloom, D. Cella et al.); (4) Confounding in Health Services Research: Issues and Solutions (F. Shaya and A. Gu). ECONOMICS OF INNOVATIVE BIOPHARMACEUTICALS (5) Prices, Regulation and Innovation in Pharmaceuticals and Biotechnology (J. Hay); (6) The History and Economics of Pharmaceutical Patents (A. Wertheimer and T. Santilla). INNOVATION IN SYSTEM-OF-SYSTEMS APPLICATIONS (7) Modernization of the Joint Forces Ammunition Logistics Information System: Agile, Adaptive, Serving the Modular Forces (I. Farquhar and A. Sorkin); (8) Innovation in Health, Environmental and Safety Research Infrastructure (I. Farquhar et al); (9) The Value of Information Technology Innovation in Healthcare (M. Bhor et al); (10) Costing Innovation (N. Hulkower).