Product Safety Evaluation Handbook, Second Edition PDF Download
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Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 9781420000559
Category : Medical
Languages : en
Pages : 708
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Book Description
"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 C. Gad
Publisher: CRC Press
ISBN: 9781420000559
Category : Medical
Languages : en
Pages : 708
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Book Description
"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
ISBN: 9781560324799
Category : Medical
Languages : en
Pages : 944
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Book Description
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
ISBN:
Category : Business & Economics
Languages : en
Pages : 712
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Book Description
"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 C. Gad
Publisher: CRC Press
ISBN: 9781420025187
Category : Medical
Languages : en
Pages : 424
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Book Description
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
ISBN: 9781439876084
Category : Medical
Languages : en
Pages : 576
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Book Description
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: Shayne C. Gad
Publisher: CRC Press
ISBN: 1560327693
Category : Medical
Languages : en
Pages : 419
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Book Description
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: Vitaly Herasevich, , , MSc
Publisher: CRC Press
ISBN: 9781498766470
Category : Medical informatics
Languages : en
Pages : 0
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Book Description
Governments and clinical providers are investing billions of dollars in health information technologies. This book provides an easy-to-read reference outlining the basic concepts, theory, and methods required to perform a systematic evaluation of HIT.
Author: Jean-Christophe Rufin
Publisher: W. W. Norton & Company
ISBN: 9780393323399
Category :
Languages : en
Pages : 1092
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Book Description
The sequel to The Abyssinian finds Jean-Baptiste Poncet in Persia practicing medicine for the Shah and trying to rescue his wife and daughter from inside the walls of a city under attack. Reprint. 11,500 first printing.
Author: E. Scott Geller
Publisher: CRC Press
ISBN: 1420032569
Category : Medical
Languages : en
Pages : 560
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Book Description
You cannot improve your organization's safety performance to enviable levels without addressing human behavior and attitude effectively. The only comprehensive reference on the psychology of the human dynamics of safety, The Psychology of Safety Handbook shows you how to apply psychology to improve safety and health in your organization. Dr. Geller
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097398
Category : Medical
Languages : en
Pages : 914
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Book Description
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
