Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Validation And Regulatory Acceptance Of Toxicological Test Methods PDF full book. Access full book title Validation And Regulatory Acceptance Of Toxicological Test Methods.
| Author | : DIANE Publishing Company |
| Publisher | : DIANE Publishing |
| Total Pages | : 95 |
| Release | : 1998-02 |
| Genre | : |
| ISBN | : 0788142321 |
| Author | : |
| Publisher | : |
| Total Pages | : 130 |
| Release | : 1997 |
| Genre | : Toxicity testing |
| ISBN | : |
| Author | : Errol Zeiger |
| Publisher | : |
| Total Pages | : 105 |
| Release | : 1998-04 |
| Genre | : |
| ISBN | : 9780788148552 |
This report was developed to recommend criteria & processes for validation & regulatory acceptance of toxicological testing methods that would be useful to Federal agencies & the scientific community. The specific goals of the report include: communicating the criteria & procedures to employ in considering new & revised test methods; encouraging the development, validation, & evaluation of new & revised test methods; contributing to regulatory acceptance & encouraging the use of valid new & revised test methods, & encouraging the reduction & refinement of animal use in testing.
| Author | : Chantra Eskes |
| Publisher | : Springer |
| Total Pages | : 407 |
| Release | : 2016-09-26 |
| Genre | : Medical |
| ISBN | : 3319338269 |
This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
| Author | : Kenneth Olden |
| Publisher | : |
| Total Pages | : 41 |
| Release | : 1997-02 |
| Genre | : |
| ISBN | : 9780788142338 |
The purpose of the NTP Workshop on Validation & Regulatory Acceptance of Alternative Toxicological Test Methods was to receive comments & recommendations from the public & invited experts on their draft report. It provided recommended criteria & processes for the validation & regulatory acceptance of new & revised toxicological testing methods. This report is a summary of the recommend. developed by the workshop participants. One of the goals of the NTP is developing & validating improved alternative toxicological test methods. The NTP Revit. Act directed NIEHS to: establish criteria for the validation & regulatory acceptance of alternative testing methods: & to recommend a process through which scientifically validated alternative methods can be accepted for regulatory use.
| Author | : Frank A Barile |
| Publisher | : CRC Press |
| Total Pages | : 368 |
| Release | : 2013-04-02 |
| Genre | : Medical |
| ISBN | : 1842145282 |
Nationally, toxicology programs have evolved from a traditional exploration of the chemistry and applied toxicity of chemicals and drugs to a more comprehensive study of toxicology and toxicology testing as independent entities. Consequently, the second edition of Principles of Toxicology Testing starts with basic toxicological principles, including absorption, distribution, metabolism, and elimination of toxins, including chemicals and drugs. The book then continues with animal (in vivo) and in vitro toxicology testing methods associated with toxicological analysis and preclinical drug development. As in the first edition, the book begins with an introduction into the fundamentals of toxicology (Section I) to prepare readers for the subsequent topics and continues through with a discussion of toxicokinetics and human risk assessment. This introductory material is useful in understanding the applications of toxicology testing. Section II describes the fundamental principles of toxicology testing in animals in greater detail. This section describes acute toxicity studies as well as subchronic and chronic studies performed on animals. Special emphasis is placed on study design and determination of classical indicators for acute and chronic testing, such as the LD50. The book examines other short- and long-term animal toxicity testing methodologies, including dermal, ocular, and reproductive toxicity testing. In addition, mutagenicity and carcinogenicity studies are also discussed in separate chapters. Section III introduces and discusses in vitro alternatives to animal toxicology tests. This section emphasizes cell culture methodology and cellular methods for acute systemic toxicity, target organ toxicity, and local toxicity. The contributors present the advantages and disadvantages of alternative methods. They also describe the use of high-throughput screening and its applications, the concepts of standardization and validation of in vitro techniques (especially large, organized validation efforts currently supported by US and EU regulatory agencies), and the theories supporting the development of in vitro methodologies. This second edition is a must-read for undergraduate and graduate toxicology students. Industrial and academic research centers will also find the text useful for establishing a toxicology testing laboratory.
| Author | : Harry Salem |
| Publisher | : CRC Press |
| Total Pages | : 616 |
| Release | : 2003-03-26 |
| Genre | : Medical |
| ISBN | : 0203008790 |
Bringing together the recent and relevant contributions of over 125 scientists from industry, government, and academia in North America and Western Europe, Alternative Toxicological Methods explores the development and validation of replacement, reduction, and refinement alternatives (the 3Rs) to animal testing. Internationally recognized scientist
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 270 |
| Release | : 2006-04-07 |
| Genre | : Nature |
| ISBN | : 0309164869 |
Toxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.
| Author | : Michael Balls |
| Publisher | : Springer |
| Total Pages | : 258 |
| Release | : 2012-03-12 |
| Genre | : Medical |
| ISBN | : 9781461430544 |
The central theme running through this volume on New Technologies for Toxicity Testing is the development and application of advanced techniques for cell and tissue culture, as well as new markers and endpoints of toxicity, as alternatives to the traditional paradigm of relying on data from laboratory animal tests to undertake labelling and risk assessment. Of course, many of the techniques and methods described in this volume are in the early stages of development, and much work will be needed to ensure their further improvement, optimisation and validation. However, we are confident that this will be achieved and that, just as with the in vitro assays that were validated and granted regulatory acceptance over the last decade, these, and many other new, advanced methods, will likewise become part of the toxicologist’s improved toolbox for coping with increasingly stringent and numerous regulatory requirements and test chemicals, while placing less reliance on traditional testing paradigms.
| Author | : John M. Frazier |
| Publisher | : CRC Press |
| Total Pages | : 312 |
| Release | : 1992-01-31 |
| Genre | : Medical |
| ISBN | : 9780824786144 |
This volume focuses on the potential application of in vitro procedures to identify and quantify the toxicological risk to target organs associated with the use of commerical products and therapeutic drugs.;Revealing how the results of in vitro toxicity testing can be used in safety assessment, In Vitro Toxicity Testing: explores whether existing test methods can accomplish the necessary goals and, if not, what research is needed to make these techniques a practical reality; presents the current status of toxicity testing in the areas of hepatotoxicity, renal toxicity, ocular irritation, and many others; outlines the role of validation in technology transfer from the research laboratory to safety evaluation; examines testing strategies and regulatory acceptance and addresses common concerns about the ultimate utilization of available methods in chemical safety/hazard considerations; and analyzes the perspective of industrial and regulatory agencies on the application of in vitro toxicity testing.;Generously referenced with over 1400 literature citations, In Vitro Toxicity Testing is for academic, industrial, and regulatory toxicologists; applied, molecular, and cell biologists; pharmacologists; animal welfare activists; and graduate students in pharmacology and toxicology courses.
