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Showing 1 - 12 of 16 results for “shayne c gad”
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  • Integrated Safety and Risk Assessment for Medical Devices and Combination Products

    by Shayne C. Gad ...
    While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and ... Read more

    $205.99 CAD

  • Safety Pharmacology in Pharmaceutical Development

    Approval and Post Marketing Surveillance, Second Edition

    by Shayne C. Gad ...
    Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions. This volume covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. ... Read more

    $133.99 CAD

  • Nonclinical Drug Administration

    Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

    by Shayne C. Gad, Charles B. Spainhour ...
    If we will ever achieve Paul Ehrlich’s "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to ... Read more

    $375.99 CAD

  • Contract Research and Development Organizations

    Their Role in Global Product Development

    by Shayne C. Gad, Charles B. Spainhour ...
    Series series Biomedical and Life Sciences (R0)
    The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 ... Read more

    $179.99 CAD

  • The Selection and Use of Contract Research Organizations

    by Shayne C. Gad ...
    Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your ... Read more

    $98.99 CAD

  • Safety Evaluation of Pharmaceuticals and Medical Devices

    International Regulatory Guidelines

    by Shayne C. Gad ...
    Series series Biomedical and Life Sciences (R0)
    The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as ... Read more

    $179.99 CAD

  • Safety Evaluation in the Development of Medical Devices and Combination Products

    by Shayne C. Gad, Marian G. McCord ...
    Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l ... Read more

    $375.99 CAD

  • Acute Toxicology Testing

    by Shayne C. Gad, Christopher P. Chengelis ...
    Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will ... Read more

    $116.79 CAD

  • Acute Toxicology Testing

    Perspectives and Horizons

    by Shayne C. Gad, Christopher P. Chengelis ...
    Acute toxicology testing constitutes the first line of defense against potentially dangerous chemicals. This book provides a detailed presentation of protocols for each of the common designs, reviews their development and objectives, discusses the types of data they generate, and examines the current status of alternative test designs and models. F ... Read more

    $394.99 CAD

  • Contract Research and Development Organizations-Their History, Selection, and Utilization

    by Shayne C. Gad, Charles B. Spainhour, David G. Serota ...
    Series series Biomedical and Life Sciences (R0)
    This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics:· The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.· Study directors and ... Read more

    $115.99 CAD

  • Drug Safety Evaluation

    by Shayne Cox Gad, Dexter W. Sullivan Jr. ...
    Series series Pharmaceutical Development Series
    Drug Safety EvluationComprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeuticsThis fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, ... Read more

    $361.99 CAD

  • Biomaterials, Medical Devices, and Combination Products

    Biocompatibility Testing and Safety Assessment

    by Shayne Cox Gad, Samantha Gad-McDonald ...
    Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical ... Read more

    $375.99 CAD