Analysis & Pharmaceutical Quality Products

  • Pharmaceutical Computer Systems Validation

    Quality Assurance, Risk Management and Regulatory Compliance, 2nd Edition

    Edited by Guy Wingate

    Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements…

    Hardback – 2010-02-23
    CRC Press

  • Implementing Quality in Laboratory Policies and Processes

    Using Templates, Project Management, and Six Sigma, 1st Edition

    By Donnell R. Christian, Jr., Stephanie Drilling

    In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in…

    Hardback – 2009-11-24
    CRC Press

  • Modern Pharmaceutics Volume 1

    Basic Principles and Systems, Fifth Edition, 5th Edition

    Edited by Alexander T. Florence, Juergen Siepmann

    With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics.Key topics in Volume 1 include:• principles of drug absorption, chemical kinetics, and…

    Hardback – 2009-05-28
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Modern Pharmaceutics, Volume 2

    Applications and Advances, Fifth Edition, 5th Edition

    Edited by Alexander T. Florence, Juergen Siepmann

    Volume 2 addresses the applications and approaches in advanced drug delivery systems, including transdermal, pulmonary, and ocular routes. In addition, this text discusses the impact of the shift to personalized medicines in the fields of pharmaceutical biotechnology, pharmacogenomics, and…

    Hardback – 2009-05-28
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Modern Pharmaceutics, Two Volume Set

    5th Edition

    Edited by Alexander T. Florence, Juergen Siepmann

    This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current…

    Hardback – 2009-05-22
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • 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…

    Hardback – 2008-12-02
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Microbial Limit and Bioburden Tests

    Validation Approaches and Global Requirements,Second Edition, 2nd Edition

    By Lucia Clontz

    In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/…

    Hardback – 2008-10-14
    CRC Press

  • Pharmaceutical Project Management

    2nd Edition

    Edited by Anthony Kennedy

    Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases…

    Hardback – 2008-03-17
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Preparing for FDA Pre-Approval Inspections

    A Guide to Regulatory Success, Second Edition, 2nd Edition

    Edited by Martin D. Hynes

    This Second Edition is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design,…

    Hardback – 2008-03-05
    CRC Press
    Drugs and the Pharmaceutical Sciences

  • Validation of Pharmaceutical Processes

    3rd Edition

    Edited by James P. Agalloco, Frederick J. Carleton

    Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many…

    Hardback – 2007-09-25
    CRC Press

  • Validation and Qualification in Analytical Laboratories

    2nd Edition

    By Ludwig Huber

    This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.  With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy…

    Hardback – 2007-07-23
    CRC Press

  • Pharmaceutical and Medical Device Validation by Experimental Design

    1st Edition

    Edited by Lynn D Torbeck

    This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why…

    Hardback – 2007-06-26
    CRC Press

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