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Author: Shayne C. Gad Publisher: CRC Press ISBN: Category : Medical Languages : en Pages : 712
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: Category : Medical Languages : en Pages : 712
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
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
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
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
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: Zoë Gardner Publisher: CRC Press ISBN: 1466516941 Category : Health & Fitness Languages : en Pages : 1073
Book Description
Access to accurate, evidence-based, and clinically relevant information is essential to anyone who uses or recommends herbal products. With input from some of the most respected experts in herbal and integrative medicine, this completely revised edition of the American Herbal Products Association’s Botanical Safety Handbook reviews both traditional knowledge and contemporary research on herbs to provide an authoritative resource on botanical safety. The book covers more than 500 species of herbs and provides a holistic understanding of safety through data compiled from clinical trials, pharmacological and toxicological studies, medical case reports, and historical texts. For each species, a brief safety summary is provided for quick reference, along with a detailed review of the literature. Easily understood classification systems are used to indicate the safety of each listed species and the potential for the species to interact with drugs. Enhancements to the Second Edition include: Classification of each herb with both a safety rating and a drug interaction rating More references listed for each individual herb, vetted for accuracy Specific information on adverse events reported in clinical trials or case reports Safety-related pharmacology and pharmacokinetics of each herb, including drug interactions Additional information on the use of herbs by pregnant or lactating women Toxicological studies and data on toxic compounds Representing the core of the botanical trade and comprising the finest growers, processors, manufacturers, and marketers of herbal products, the mission of the AHPA is to promote the responsible commerce of herbal products. The American Herbal Products Association Botanical Safety Handbook, Second Edition ensures that this vision is attained. The book will be a valuable reference for product manufacturers, healthcare practitioners, regulatory agencies, researchers, and consumers of herbal products.
Author: Jean-Christophe Rufin Publisher: W. W. Norton & Company ISBN: 9780393323399 Category : Languages : en Pages : 1092
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: Jerald Silverman Publisher: CRC Press ISBN: 1466565470 Category : Medical Languages : en Pages : 682
Book Description
Since its establishment by USDA regulation in the mid-1980s, the Institutional Animal Care and Use Committee (IACUC) has evolved as the premier instrument of animal welfare oversight within research institutions in the United States. By addressing questions and problems that often confront institutions, The IACUC Handbook, Second Edition provides accurate, succinct answers. It features comprehensive updates for all pertinent federal laws, regulations, and policies. It also contains an expanded survey of IACUC practices from institutions around the nation. With accessible information, this new editionprovides a foundation for those attempting to understand and implement the many and varied responsibilities of these committees.
Author: Shayne Cox Gad Publisher: John Wiley & Sons ISBN: 1119755875 Category : Medical Languages : en Pages : 996
Book Description
Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This 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, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.
Author: Shayne C. Gad
Author: Shayne C. Gad
Author: Shayne C. Gad
Author: Shayne C. Gad
Author: Shayne C. Gad
Author: Shayne C. Gad
Author: Shayne C. Gad
Author: Zoë Gardner
Author: Jean-Christophe Rufin
Author: Jerald Silverman
Author: Shayne Cox Gad