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Author: Shayne Cox Gad Publisher: John Wiley & Sons ISBN: 1119097398 Category : Medical Languages : en Pages : 914
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
Author: Shayne Cox Gad Publisher: John Wiley & Sons ISBN: 1119097398 Category : Medical Languages : en Pages : 914
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
Author: Ramesh C. Gupta Publisher: Academic Press ISBN: 9780123820334 Category : Medical Languages : en Pages : 1220
Book Description
Reproductive toxicology is a complex subject dealing with three components—parent, placenta, and fetus—and the continuous changes that occur in each. Reproductive and Developmental Toxicology is a comprehensive and authoritative resource providing the latest literature enriched with relevant references describing every aspect of this area of science. It addresses a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, food additives, nutraceuticals and pharmaceuticals, and metals, among others. With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages, and is the only resource to include reproductive and developmental toxicity in domestic animals, fish, and wildlife. Provides a complete, integrated source of information on the key risk stages during reproduction and development Includes coverage of emerging science such as stem cell application, toxicoproteomics, metabolomics, phthalates, infertility, teratogenicity, endocrine disruption, surveillance and regulatory considerations, and risk assessment Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309184134 Category : Medical Languages : en Pages : 158
Book Description
The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Author: Mark A. Suckow Publisher: Elsevier ISBN: 0080454321 Category : Science Languages : en Pages : 928
Book Description
The Laboratory Rat, Second Edition features updated information on a variety of topics including: rat genetics and genomics, both spontaneous and induced disease; state-of-the-art technology for housing and husbandry; occupational health, and experimental models. A premier source of information on the laboratory rat that will be of interest to veterinary and medical students, senior graduate, graduate students, post-docs and researchers who utilize animals in biomedical research. At least 50% new information than first edition Includes topics on rat genetics and genomics, occupational health, and experimental models The premier source of information on the laboratory rat
Author: Joint FAO/WHO Expert Committee on Food Additives Publisher: World Health Organization ISBN: 9789241660532 Category : Business & Economics Languages : en Pages : 206
Book Description
The monographs in this volume summarize data on the veterinary drug residues that were evaluated toxicologically by the Committee, which included three antimicrobial agents (cefuroxime, flumequine and pirlimycin), two insecticides (cyhalothrin, and cypermethrin and alpha-cypermethrin) and one production aid (ractopamine). The Committee also evaluated the safety of low levels of the antimicrobial agent chloramphenicol in animal products. This volume and others in the WHO Food Additives Series contain information that is useful to those who produce and use food additives and veterinary drugs and those involved with controlling contaminants in food, government and food regulatory officers, industrial testing laboratories, toxicological laboratories, and universities.
Author: Publisher: Academic Press ISBN: 0080922015 Category : Medical Languages : en Pages : 2407
Book Description
The Handbook of Pesticide Toxicology is a comprehensive, two-volume reference guide to the properties, effects, and regulation of pesticides that provides the latest and most complete information to researchers investigating the environmental, agricultural, veterinary, and human-health impacts of pesticide use. Written by international experts from academia, government, and the private sector, the Handbook of Pesticide Toxicology is an in-depth examination of critical issues related to the need for, use of, and nature of chemicals used in modern pest management. This updated 3e carries on the book’s tradition of serving as the definitive reference on pesticide toxicology and recognizes the seminal contribution of Wayland J. Hayes, Jr., co-Editor of the first edition. Feature: Presents a comprehensive look at all aspects of pesticide toxicology in one reference work. Benefit: Saves researchers time in quickly accessing the very latest definitive details on toxicity of specific pesticides as opposed to searching through thousands of journal articles. Feature: Clear exposition of hazard identification and dose response relationships in each chapter featuring pesticide agents and actions Benefit: Connects the experimental laboratory results to real-life applications in human health, animal health and the environment. Feature: All major classes of pesticide considered. Benefit: Provides relevance to a wider variety of researchers who are conducting comparative work in pesticides or their health impacts. Feature: Different routes of exposure critically evaluated. Benefit: Connects the loop between exposure and harmful affects to those who are researching the affects of pesticides on humans or wildlife.
Author: A. Wallace Hayes Publisher: CRC Press ISBN: 1842145371 Category : Medical Languages : en Pages : 2184
Book Description
Hayes' Principles and Methods of Toxicology has long been established as a reliable reference to the concepts, methodologies, and assessments integral to toxicology. The new sixth edition has been revised and updated while maintaining the same high standards that have made this volume a benchmark resource in the field. With new authors and new chap
Author: Shayne Cox Gad
Author: Shayne Cox Gad
Author: Ramesh C. Gupta
Author: Institute of Medicine
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Author: Mark A. Suckow
Author: Myron A. Mehlman
Author: Joint FAO/WHO Expert Committee on Food Additives
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Author: 
Author: A. Wallace Hayes