Author : Shayne C. Gad
Publisher : CRC Press
Page : 708 pages
File Size : 33,35 MB
Release : 1999-07-02
Category : Medical
ISBN : 9781420000559
"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."
Author : Andreas F von Recum
Publisher : CRC Press
Page : 944 pages
File Size : 20,39 MB
Release : 1998-12-18
Category : Medical
ISBN : 9781560324799
This handbook addresses the needs of those who are involved in inventing, developing, and testing implants and are concerned about the interactions between biomaterial and body tissue. The authors explore the physical, chemical, mechanical and regulatory considerations of synthetic materials used in surgical and implant procedures, and how these factors impact the latest developments and new approaches. This updated edition provides the biomaterials professional with necessary information on a range of issues, including bulk characterization, surface evaluations, toxicological evaluations, in vitro methods for safety evaluation, methods for evaluating materials in special applications, surgical considerations, systems implantology, soft and hard tissue history, regulatory aspects, and clinical trials.
Author : Shayne C. Gad
Publisher : CRC Press
Page : 712 pages
File Size : 22,68 MB
Release : 1999-07-02
Category : Business & Economics
ISBN :
"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 918 pages
File Size : 19,58 MB
Release : 2016-11-18
Category : Medical
ISBN : 1119097401
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author : Shayne C. Gad
Publisher : CRC Press
Page : 424 pages
File Size : 40,78 MB
Release : 2001-07-19
Category : Medical
ISBN : 9781420025187
This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.
Author : Shayne C. Gad
Publisher : CRC Press
Page : 576 pages
File Size : 21,78 MB
Release : 2001-12-04
Category : Medical
ISBN : 9781439876084
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-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.
Author : Chuck Hellier
Publisher : McGraw Hill Professional
Page : 724 pages
File Size : 33,84 MB
Release : 2012-09-15
Category : Technology & Engineering
ISBN : 007177713X
A complete, up-to-date guide to the leading product testing standard Fully revised to cover the latest nondestructive testing (NDT) procedures, this practical resource reviews established and emerging methods for examining materials without destroying them or altering their structure. Handbook of Nondestructive Evaluation, Second Edition offers in-depth details on the background, benefits, limitations, and applications of each method. The book provides advice on how to interpret results and formulate accurate decisions based on your findings. New chapters on digital radiography, ultrasonic phased array testing, and ultrasonic guided wave inspection are included. This is a must-have reference for NDT certification candidates, engineers, metallurgists, quality control specialists, and anyone involved in product design, manufacture, or maintenance. Handbook of Nondestructive Evaluation, Second Edition covers: Introduction to nondestructive testing Discontinuities—origins and classification Visual testing Penetrant testing Magnetic particle testing Radiographic testing Ultrasonic testing Eddy current testing Thermal infrared testing Acoustic emission testing Digital radiography Ultrasonic phased array testing Ultrasonic guided wave inspection
Author : Nicholas J. Bahr
Publisher : CRC Press
Page : 444 pages
File Size : 19,3 MB
Release : 2018-10-08
Category : Technology & Engineering
ISBN : 1466551615
We all know that safety should be an integral part of the systems that we build and operate. The public demands that they are protected from accidents, yet industry and government do not always know how to reach this common goal. This book gives engineers and managers working in companies and governments around the world a pragmatic and reasonable approach to system safety and risk assessment techniques. It explains in easy-to-understand language how to design workable safety management systems and implement tested solutions immediately. The book is intended for working engineers who know that they need to build safe systems, but aren’t sure where to start. To make it easy to get started quickly, it includes numerous real-life engineering examples. The book’s many practical tips and best practices explain not only how to prevent accidents, but also how to build safety into systems at a sensible price. The book also includes numerous case studies from real disasters that describe what went wrong and the lessons learned. See What’s New in the Second Edition: New chapter on developing government safety oversight programs and regulations, including designing and setting up a new safety regulatory body, developing safety regulatory oversight functions and governance, developing safety regulations, and how to avoid common mistakes in government oversight Significantly expanded chapter on safety management systems, with many practical applications from around the world and information about designing and building robust safety management systems, auditing them, gaining internal support, and creating a safety culture New and expanded case studies and "Notes from Nick’s Files" (examples of practical applications from the author’s extensive experience) Increased international focus on world-leading practices from multiple industries with practical examples, common mistakes to avoid, and new thinking about how to build sustainable safety management systems New material on safety culture, developing leading safety performance indicators, safety maturity model, auditing safety management systems, and setting up a safety knowledge management system
Author : Shayne C. Gad
Publisher : CRC Press
Page : 419 pages
File Size : 22,8 MB
Release : 2000-11-02
Category : Medical
ISBN : 1560327693
Toxicology has made tremendous strides in the sophistication of the models used to identify and understand the mechanisms of agents that can harm or kill humand and other higher organisms. Non-animals or in vitro models started to gain significant use in the 1960s. As a result of the increased concern over animal welfare, economic factors, and the need for greater sensitivity and understanding of mechanisms, interest in in vitro^n models has risen. This volume demonstrates that there now exists a broad range of in vitro models for use in either identifying or understanding most forms of toxicity. The availability of in vitro models spans both the full range of endpoints (irritation, sensitization, lethality, mutagenicity, and devlopmental toxicity) and the full spectrum of target organ systems (skin, eye, heart, liver, kidney, nervous system, etc.). Chapters are devoted to each of these speciality areas from a perspective of presenting the principal models and their uses and limitations. Chapters that overview the principles involved in the general selection and use of models, and that address the issues of safety concerns and regulatory acceptance of these methods are also included.
Author : Florian
Publisher : CRC Press
Page : 394 pages
File Size : 21,35 MB
Release : 2008-12-22
Category : Law
ISBN : 1420071130
Behavioral science has revealed a wealth of information concerning violence assessment in a wide variety of situations, but the challenge confronted by those dealing with potentially hostile populations is the effective application of this knowledge. Now in its second edition, Violence Assessment and Intervention: The Practitioner‘s Handbook, Secon
