Pharmaceutical Science Regulatory Products

  • Drug Discovery and Development, Third Edition

    3rd Edition

    Edited by James J. O'Donnell, John Somberg, Vincent Idemyor, James T. O'Donnell

    The Process of New Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development…

    Hardback – 2019-12-13 
    CRC Press

  • Innovative Statistics in Regulatory Science

    1st Edition

    By Shein-Chung Chow

    Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in…

    Hardback – 2019-11-11 
    Chapman and Hall/CRC
    Chapman & Hall/CRC Biostatistics Series

  • Pharmaceutical Photostability and Stabilization Technology

    1st Edition

    Edited by Joseph T. Piechocki, Karl Thoma

    Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on…

    Paperback – 2019-09-23
    CRC Press

  • 21 CFR Part 11

    Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry, 1st Edition

    By Orlando López

    Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies…

    Paperback – 2019-09-23
    CRC Press

  • Computer-Aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates

    1st Edition

    By Jujjvarapu Satya Eswari, Swasti Dhagat, Manisha Yadav

    Increase in antibiotic resistance has forced researchers to develop new drugs against microorganisms. Lipopeptides are produced as secondary metabolites by some microorganisms. Computer-aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates provides the identification of novel…

    Hardback – 2019-09-11
    CRC Press

  • Design Controls for the Medical Device Industry, Third Edition

    3rd Edition

    By Marie B. Teixeira

    This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design…

    Hardback – 2019-08-15
    CRC Press

  • The Pharmaceutical Regulatory Process

    2nd Edition

    Edited by Ira R. Berry, Robert P. Martin

    This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by…

    Paperback – 2019-06-07
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • 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 – 2019-03-01
    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 – 2019-02-18
    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

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