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  • Navigating the FDA Regulatory Processes

    An Integrated Clinical and Engineering Approach

    This book provides a unique knowledge source of the FDA’s regulatory processes to anyone interested in the development and approval of biomedical products.Navigating the FDA Regulatory Processes will be of particular importance for those innovating in biomedical devices, pharmacological therapies, and combination products, who are interested in considering regulatory affairs early on in product ... Leer más

    $179.99 USD

  • Drug Delivery

    An Integrated Clinical and Engineering Approach

    Integrating the clinical and engineering aspects of drug delivery, this book offers a much needed comprehensive overview and patient-oriented approach for enhanced drug delivery optimization and advancement. Starting with an introduction to the subject and pharmacokinetics, it explores advances for such topics as oral, gastroretentive, intravitreal, and intrathecal drug delivery, as well as ... Leer más

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  • Clinical Research Coordinator Handbook, Fourth Edition

    In this fully revised and expanded fourth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The books five appendices include a directory of CRC resources, updated forms and checklists, ... Leer más

    $9.99 USD o gratis con Kobo Plus

  • Clinical Research Coordinator Handbook, 5th edition

    “This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”— Journal of Hospital LibrarianshipIn this fully revised and expanded fifth edition ... Leer más

    $9.99 USD o gratis con Kobo Plus

  • Malignant

    How Bad Policy and Bad Evidence Harm People with Cancer

    How hype, money, and bias can mislead the public into thinking that many worthless or unproven treatments are effective.Each week, people read about new and exciting cancer drugs. Some of these drugs are truly transformative, offering major improvements in how long patients live or how they feel—but what is often missing from the popular narrative is that, far too often, these new drugs have ... Leer más

    $29.99 USD

  • The Combination Products Handbook

    A Practical Guide for Combination Products and Other Combined Use Systems

    Edición de Susan Neadle ...
    Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled ... Leer más

    $82.99 USD

  • Pharmaceutical Lifecycle Management

    Making the Most of Each and Every Brand

    A comprehensive guide to optimizing the lifecycle management of pharmaceutical brandsThe mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create ... Leer más

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  • The Future of Drug Discovery

    Who Decides Which Diseases to Treat?

    The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, ... Leer más

    $40.99 USD

  • Early Drug Development

    Strategies and Routes to First-in-Human Trials

    Edición de Mitchell N. Cayen ...
    The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their ... Leer más

    $161.00 USD

  • A Clinical Trials Manual From The Duke Clinical Research Institute

    Lessons from a Horse Named Jim

    "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient ... Leer más

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  • Fast Facts: Biosimilars in Hematology and Oncology

    Biologics and biosimilars - getting decisions right

    Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – ... Leer más

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  • Quality and Safety in Pharmacy Practice

    Gain a complete understanding of the principles of quality improvement and their application to present and future pharmacy practice"This is a nice introduction to the concepts of continuous quality improvement. It is a comfortable read and is written at an elementary level in comparison to other textbooks in the pharmacy curriculum. This may be necessary, since the authors rightly conclude there ... Leer más

    $60.99 USD