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NTP Workshop on Validation and Regulatory Acceptance of Alternative Toxicological Test Methods

NTP Workshop on Validation and Regulatory Acceptance of Alternative Toxicological Test Methods
Author: Kenneth Olden
Publisher:
Total Pages: 41
Release: 1997-02
Genre:
ISBN: 9780788142338

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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.


Federal Register

Federal Register
Author:
Publisher:
Total Pages: 420
Release: 2013-11
Genre: Delegated legislation
ISBN:

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Annual Plan for Fiscal Year ...

Annual Plan for Fiscal Year ...
Author: National Toxicology Program (U.S.)
Publisher:
Total Pages: 280
Release: 1990
Genre: Toxicity testing
ISBN:

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Toxicity Assessment Alternatives

Toxicity Assessment Alternatives
Author: Harry Salem
Publisher: Springer Science & Business Media
Total Pages: 257
Release: 1999-07-02
Genre: Medical
ISBN: 1592597181

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Toxicity Assessment Alternatives: Methods, Issues, Opportunities contains a broad array of critical surveys, contributed by active and respected investigators, describing their research and offering updates on toxicity assessment alternatives, directions determined by current and future grant programs, opportunities for mechanistically based test methods to detect endocrine disruptor activity, the use of alternatives in the Department of Defense hazard assessment initiatives, and the issues and opportunities for validation and regulatory acceptance. Several of these advances make use oftransgenic models that reduce the time and cost of carcinogenicity testing. Others use tissue cultures for the assessment of endocrine disrupting chemicals. Cultures of human epidermal keratinocytes are applicable as models for sulfur mustard lesions, and in vitro protein denaturation is used as a chemical test for assessing the ocular and dermal irritation potential of cosmetic prod ucts. Molecular modeling is applied to explaining chemical toxicity. Commercially developed assay systems have undergone extensive evaluation by their manufacturers. Some of these await external valida tion, and others await acceptance by North American and European regulatory agencies. Toxicity Assessment Alternatives: Methods, Issues, Opportunities provides information from members of the scientific and regulatory communities on what has been achieved and what has been accepted in alternatives to animal testing.


Advances in Molecular Toxicology

Advances in Molecular Toxicology
Author: Claude Reiss
Publisher: VSP
Total Pages: 590
Release: 1998-02
Genre: Science
ISBN: 9789067642781

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Molecular toxicology is on the way to setting a new standard in toxic risk assessment, with the powerful help of concepts and methods developed in the fields of molecular and cellular biology. The methods of molecular toxicology are endowed with qualities not always secured in more traditional approaches to toxicity assessment. These methods are easily standardized, reliable, reproducible and require only tiny amounts of the xenobiotic. They are much simpler, faster and less costly than current tests on animals and can be implemented with modest laboratory resources. This volume of Advances in Molecular Toxicology represents a collection of invited papers presented at the First European Workshop on Molecular Toxicology in Sophia Antipolis, France, The book covers 8 selected topics in molecular toxicology. The first two are devoted to ''physics'', dealing respectively with advanced instrumentation enabling location and quantification of xenobiotics in cells and organs with ultimate precision, and computer-assisted assessment of risk (QSAR). A comprehensive and up-to-date survey of molecular toxicology in the pharmaceutical industry is contributed by a pioneer in this field. The third section addresses the effect of xenobiotics on cell-cycle actors. Sections 4--6 deal with molecular toxicology in skin, kidney, nerve, liver and pancreatic cells. The last two sections describe methods to probe DNA damage and repair, and immunotoxicity.