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Modern medicine : biomedical devices, medical gases, radiopharmaceuticals, new drug discovery, Vol.2
Discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). In the rapidly evolving landscape of modern medicine, groundbreaking innovations have emerged that are reshaping the way we approach healthcare. Modern Medicine delves into the cutting-edge realms of medical devices, medical gases, radiopharmaceuticals, and new drug discovery, offering a comprehensive exploration of these transformative fields that are revolutionizing patient care and medical practices.
Drug development and approval process
Drug discovery is the process of identifying and characterizing molecules with the potential to safely modulate disease, with a goal to bring medicines that can improve the lives of patients. It is a lengthy and resource intensive process, that requires close cooperation across multiple disciplines. Optimizing the process of drug discovery is of great interest to the pharmaceutical industry, as the efficient identification and selection of suitable drug candidates can have a dramatic impact on the cost and profitability of new medicines.
Leading Pharmaceutical Innovation : Trends and Drivers for Growth in the Pharmaceutical Industry
Pharmaceutical giants have doubled their investments in drug development in the past decade only to see new drug approvals remain constant. This book investigates and highlights a set of proactive strategies aimed at generating sustainable competitive advantage based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of cooperation and internationalization, such as open innovation in the early phases of R&D. Our findings are illustrated by cases from Europe, the US, and Asia.
Biopharmaceutical drug design and development
Biopharmaceutical Drug Design and Development, Second Edition, updates the widely successful first edition, published in 1999. This new, expanded edition investigates the dozens of new biopharmaceutical drugs that have become available since the publication of the first edition. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, such as bioinformatics, DNA microarrays, transgenics, therapeutic gene delivery, stem cells, nucleic acid-based therapeutics, and macromolecular drug delivery. Authors also study pharmacogenetics in the clinic and changes in biologic drug approval at the FDA. Biopharmaceutical Drug Design and Development, Second Edition, is a worthy sequel in the discussion on the dynamic, exciting field of biotechnology.
