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“susan neadle”

Showing 1 - 12 of 12 results for “susan neadle”
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  • Fundamentals of Biologicals Regulation

    Vaccines and Biotechnology Medicines

    by Rebecca Sheets, Christopher Hamlin, Susan Neadle, Ivana Knezevic, Mark Schenerman, Mehmet Tosun, Kathryn C. Zoon ...
    This second edition of Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides more in-depth coverage of Quality by Design, ... Read more

    $132.79 CAD

  • The Combination Products Handbook

    A Practical Guide for Combination Products and Other Combined Use Systems

    Edited by 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 ... Read more

    $114.04 CAD

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  • Health Informatics: Practical Guide, Seventh Edition

    by Robert E. Hoyt, William R. Hersh ...
    Health Informatics: Practical Guide focuses on the application of information technology in healthcare to improve individual and population health, education and research. The goal of the seventh edition is to stimulate and educate healthcare and IT professionals and students about the key topics in this rapidly changing field. Dr. William Hersh from Oregon Health & Science University is the co ... Read more

    $41.79 CAD

  • Clinical Research Coordinator Handbook, Fourth Edition

    by Deborah Norris ...
    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, ... Read more

    $9.61 CAD or Free with Kobo Plus

  • Pharmacovigilance Medical Writing

    A Good Practice Guide

    by Justina Orleans-Lindsay ...
    Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e ... Read more

    $62.99 CAD

  • Medical Product Regulatory Affairs

    Pharmaceuticals, Diagnostics, Medical Devices

    by John J. Tobin, Gary Walsh ...
    Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and ... Read more

    $116.99 CAD

  • Process Architecture in Biomanufacturing Facility Design

    Edited by Jeffery Odum, Michael C. Flickinger ...
    Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing fieldBiomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical ... Read more

    $213.99 CAD

  • Clinical Engineering Handbook

    Edited by Joseph Dyro ...
    As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The ... Read more

    $167.99 CAD

  • Generic Drugs

    A Consumer’S Self-Defense Guide

    by Clifford L. Nilsen ...
    When you purchase drug products, you dont expect them to be contaminated with antifreeze, industrial chemicals, glass, or dangerous bacteria. But this happens every day when uninformed consumers buy prescription or over-the- counter and behind-the-counter drug products.Armed with the right knowledge, you can avoid the dangers and risks of these drugs and protect yourself and your family. This ... Read more

    $11.19 CAD

  • Medical Device

    A Primer Based on Best Practices

    by Rommel Garcia ...
    This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who ... Read more

    $5.39 CAD

  • How to Validate a Pharmaceutical Process

    by Steven Ostrove ...
    Series series Expertise in Pharmaceutical Process Technology
    How to Validate a Pharmaceutical Process provides a "how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a ... Read more

    $44.79 CAD

  • The Survival Guide to EU Medical Device Regulations

    by Petri Pommelin ...
    The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously. This book gives guidance on the definitions, the key concepts and the main ... Read more

    $28.99 CAD or Free with Kobo Plus