LIBROS DEL AUTOR: shayne c gad

14 resultados para LIBROS DEL AUTOR: shayne c gad

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  • Contract Research and Development Organizations-Their History, Selection, and Utilization
    Charles B. Spainhour / David G. Serota / Shayne C. Gad
    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....
    Disponible

    124,78 €

  • Integrated Safety and Risk Assessment for Medical Devices and Combination Products
    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 bo...
    Disponible

    223,05 €

  • Contract Research and Development Organizations-Their History, Selection, and Utilization
    Charles B. Spainhour / David G. Serota / Shayne C. Gad
    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....
    Disponible

    172,28 €

  • Integrated Safety and Risk Assessment for Medical Devices and Combination Products
    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 bo...
    Disponible

    46,82 €

  • Integrated Safety and Risk Assessment for Medical Devices and Combination Products
    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 bo...
    Disponible

    221,70 €

  • Statistics and Experimental Design for Toxicologists and Pharmacologists
    Shayne C. Gad
    This fourth edition provides tools for the rigorous and critical analysis of experimental data. Assuming only basic mathematical skills, the book provides a complete and exhaustive introduction to the statistical methods available and updates all material to cover current practices. The author also provides three entirely new and up-to-the-minute chapters: one provides the firs...
    Disponible

    118,99 €

  • Safety Pharmacology in Pharmaceutical Development
    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 ...
    Disponible

    120,74 €

  • Regulatory Toxicology, Third Edition
    Shayne C. Gad
    With three new chapters on Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana, this practical book provides toxicologists essential information on the regulations that govern their jobs and products. Each chapter covers the historical events that led to the original legislation. ...
    Disponible

    359,65 €

  • Safety Evaluation of Pharmaceuticals and Medical Devices
    Shayne C. Gad
    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...
    Disponible

    209,54 €

  • Contract Research and Development Organizations
    Charles B. Spainhour / Shayne C. Gad
    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 h...
    Disponible

    208,00 €

  • Contract Research and Development Organizations
    Charles B. Spainhour / Shayne C. Gad
    Introduction.- The pharmaceutical Development Process & Testing Requirements.- The Medical Device Development Process & Testing Requirements.- Functions and Types of CROs (referencing function listings in appendices).- Selection of CROs.- Labs in China and India.- Contracting, Pricing, and Cost of Works Performed by CROs.- Monitoring Ongoing Studies and Work.- Common Problems ...
    Disponible

    268,12 €

  • Statistics and Experimental Design for Toxicologists and Pharmacologists
    Shayne C. Gad
    This fourth edition provides tools for the rigorous and critical analysis of experimental data. Assuming only basic mathematical skills, the book provides a complete and exhaustive introduction to the statistical methods available and updates all material to cover current practices. The author also provides three entirely new and up-to-the-minute chapters: one provides the firs...
    Disponible

    340,83 €

  • The Selection and Use of Contract Research Organizations
    Shayne C. Gad
    Choosing the right contract research organization (CRO) can make the difference between getting a drug or medical device to market quickly and cost-effectively and wasting valuable time and money. This book provides guidelines for selection, protocol, and contract development; discusses project management and monitoring of work; explores how to integrate efforts between groups ...
    Disponible

    88,39 €

  • Regulatory Toxicology
    Shayne C. Gad
    This practical resource provides all toxicologists and scientists with essential information on the regulations that govern the context and the content of their jobs and products. ...
    Disponible

    359,81 €