Validation and Regulatory Acceptance of Toxicological Test Methods
Author: DIANE Publishing Company
Publisher: DIANE Publishing
Published: 1998-02
Total Pages: 95
ISBN-13: 0788142321
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Validation and Regulatory Acceptance of Toxicological Test Methods
Validation and Regulatory Acceptance of Toxicological Test Methods
Author: Errol Zeiger
Publisher:
Published: 1998-04
Total Pages: 105
ISBN-13: 9780788148552
DOWNLOAD EBOOK →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.
Validation of Alternative Methods for Toxicity Testing
Author: Chantra Eskes
Publisher: Springer
Published: 2016-09-26
Total Pages: 407
ISBN-13: 3319338269
DOWNLOAD EBOOK →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.
NTP Workshop on Validation and Regulatory Acceptance of Alternative Toxicological Test Methods
Author: Kenneth Olden
Publisher:
Published: 1997-02
Total Pages: 41
ISBN-13: 9780788142338
DOWNLOAD EBOOK →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.
Principles of Toxicology Testing, Second Edition
Author: Frank A Barile
Publisher: CRC Press
Published: 2013-04-02
Total Pages: 368
ISBN-13: 1842145282
DOWNLOAD EBOOK →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.
Alternative Toxicological Methods
Author: Harry Salem
Publisher: CRC Press
Published: 2003-03-26
Total Pages: 616
ISBN-13: 0203008790
DOWNLOAD EBOOK →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
Drug Discovery and Evaluation: Methods in Clinical Pharmacology
Author: H.Gerhard Vogel
Publisher: Springer Science & Business Media
Published: 2010-12-15
Total Pages: 576
ISBN-13: 3540898905
DOWNLOAD EBOOK →Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
New Technologies for Toxicity Testing
Author: Michael Balls
Publisher: Springer
Published: 2012-03-12
Total Pages: 258
ISBN-13: 9781461430544
DOWNLOAD EBOOK →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.
In-Vitro Toxicity Testing
Author: John M. Frazier
Publisher: CRC Press
Published: 1992-01-31
Total Pages: 312
ISBN-13: 9780824786144
DOWNLOAD EBOOK →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.
