Pharmaceutical Science Regulatory Products

  • Ewing's Analytical Instrumentation Handbook, Fourth Edition

    4th Edition

    Edited by Nelu Grinberg, Sonia Rodriguez

    This handbook is a guide for workers in analytical chemistry who need a starting place for information about a specific instrumental technique. It gives a basic introduction to the techniques and provides leading references on the theory and methodology for an instrumental technique. This edition…

    Hardback – 2019-03-05 
    CRC Press

  • Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

    7th Edition

    Edited by Graham P. Bunn

    This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting.…

    Hardback – 2019-02-22 
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Meta-Regulation in Practice

    Beyond Normative Views of Morality and Rationality, 1st Edition

    By F.C. Simon

    Meta-regulation presents itself as a progressive policy approach that can manage complexity and conflicting objectives better than traditional command and control regulation. It does this by ‘harnessing’ markets and enlisting a broad range of stakeholders to reach a more inclusive view of the…

    Paperback – 2019-02-04
    Routledge
    Routledge Advances in Sociology

  • The Regulation of Dietary Supplements

    A Historical Analysis, 1st Edition

    By Stephen J. Pintauro

    This book documents the long, still ongoing battle between the US Food and Drug Administration and the dietary supplement industry. It presents the complex, often subtle, and sometimes overlooked series of events that had a major impact on how dietary supplements are manufactured, marketed, sold,…

    Hardback – 2018-12-13
    CRC Press

  • Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

    1st Edition

    By Orlando Lopez

    Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance…

    Hardback – 2018-10-02
    Productivity Press

  • Regulatory Toxicology, Third Edition

    3rd Edition

    Edited by Shayne C. Gad

    This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by…

    Hardback – 2018-08-01
    CRC Press

  • Biosimilarity

    The FDA Perspective, 1st Edition

    By Sarfaraz K. Niazi

    Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of…

    Hardback – 2018-07-25
    CRC Press

  • Handbook of Medical Device Regulatory Affairs in Asia

    Second Edition, 2nd Edition

    Edited by Jack Wong, Raymond Tong

    Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and…

    Hardback – 2018-04-20
    Pan Stanford

  • Chromatographic Techniques in the Forensic Analysis of Designer Drugs

    1st Edition

    Edited by Teresa Kowalska, Mieczyslaw Sajewicz, Joseph Sherma

    There is a dramatic rise of novel drug use due to the increased popularity of so-called designer drugs. These synthetic drugs can be illegal in some countries, but legal in others and novel compounds unknown to drug chemistry emerge monthly. This thoughtfully constructed edited reference presents…

    Hardback – 2018-02-06
    CRC Press
    Chromatographic Science Series

  • Measuring Elemental Impurities in Pharmaceuticals

    A Practical Guide, 1st Edition

    By Robert Thomas

    Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>…

    Hardback – 2018-02-02
    CRC Press
    Practical Spectroscopy

  • Unity in Diversity and the Standardisation of Clinical Pharmacy Services

    Proceedings of the 17th Asian Conference on Clinical Pharmacy (ACCP 2017), July 28-30, 2017, Yogyakarta, Indonesia, 1st Edition

    Edited by Elida Zairina, Junaidi Khotib, Chrismawan Ardianto, Syed Azhar Syed Sulaiman, Charles D. Sands III, Timothy E. Welty

    Unity in Diversity and the Standardisation of Clinical Pharmacy Services represents the proceedings of the 17th Asian Conference on Clinical Pharmacy (ACCP 2017), held 28—30 July 2017 in Yogyakarta, Indonesia. The primary aim of ACCP 2017 was to bring together experts from all fields of clinical…

    Hardback – 2017-12-12
    CRC Press

  • Embedding New Technologies into Society

    A Regulatory, Ethical and Societal Perspective, 1st Edition

    Edited by Diana M. Bowman, Elen Stokes, Arie Rip

    The embedding of any new technologies in society is challenging. The evolving state of the scientific art, often-unquantifiable risks and ill-defined developmental trajectories have the potential to hinder innovation and/or the commercial success of a technology. The are, however, a number of tools…

    Hardback – 2017-09-11
    Pan Stanford

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