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“david j mazzo”

Showing 1 - 12 of 12 results for “david j mazzo”
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  • International Stability Testing

    Edited by David J. Mazzo ...
    In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, ... Read more

    $359.99 CAD

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  • 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

  • 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

    $11.99 CAD

  • Handbook of Food Safety Engineering

    Edited by Da-Wen Sun ...
    This book presents a comprehensive and substantial overview of the emerging field of food safety engineering, bringing together in one volume the four essential components of food safety:the fundamentals of microbial growthfood safety detection techniquesmicrobial inactivation techniquesfood safety management systemsWritten by a team of highly active international experts with both academic and ... Read more

    $463.99 CAD

  • Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

    Edited by Hamid Mollah, Harold Baseman, Mike Long ...
    Series Book 4 - Wiley Series in Biotechnology and Bioengineering
    Sets forth tested and proven risk management practices in drug manufacturingRisk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management ... Read more

    $163.99 CAD

  • Pharmaceutical Quality by Design

    A Practical Approach

    Edited by Walkiria S. Schlindwein, Mark Gibson ...
    Series series Advances in Pharmaceutical Technology
    A practical guide to Quality by Design for pharmaceutical product developmentPharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative ... Read more

    $108.99 CAD

  • Food Science and Technology

    Edited by Geoffrey Campbell-Platt ...
    Food Science and Technology, Second Edition is a comprehensive text and reference book designed to cover all the essential elements of food science and technology, including all core aspects of major food science and technology degree programs being taught worldwide. The book is supported by the International Union of Food Science and Technology and comprises 21 chapters, carefully written in a ... Read more

    $98.99 CAD

  • Handbook of Validation in Pharmaceutical Processes, Fourth Edition

    Edited by James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell ...
    Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. ... Read more

    $88.99 CAD

  • Global New Drug Development

    An Introduction

    by Jan A. Rosier, Mark A. Martens, Josse R. Thomas ...
    Series series ULLA Series in Pharmaceutical Sciences
    The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of ... Read more

    $131.99 CAD

  • Specification of Drug Substances and Products

    Development and Validation of Analytical Methods

    Edited by Thomas W. Rosanske, Christopher M. Riley ...
    Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing ... Read more

    $106.39 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

    $117.99 CAD