Statistical Evaluation of Mutagenicity Test Data

Statistical Evaluation of Mutagenicity Test Data
Author: David J. Kirkland
Publisher: Cambridge University Press
Total Pages: 316
Release: 2008-01-03
Genre: Medical
ISBN: 9780521048149

This rigorous and practical account of the interpretation of mutagenicity test data draws upon the expertise of toxicologists and statisticians. Chemicals, such as drugs, food additives and pesticides, all need careful screening to eliminate potentially mutagenic compounds.

Basic Mutagenicity Tests

Basic Mutagenicity Tests
Author: David J. Kirkland
Publisher: Cambridge University Press
Total Pages: 164
Release: 1990-08-31
Genre: Medical
ISBN: 9780521393478

A summary of the essential texts that must be performed on all new compounds before they can be registered for use in the UK.

Supplementary Mutagenicity Tests

Supplementary Mutagenicity Tests
Author: United Kingdom Environmental Mutagen Society. Sub-Committee on Guidelines for Mutagenicity Testing
Publisher: Cambridge University Press
Total Pages: 179
Release: 1993-11-11
Genre: Medical
ISBN: 052145073X

Originally published in 1993, this volume describes supplementary tests used to assess risks of in vitro mutagenicity when basic safety tests were inconclusive.

Cosmetics

Cosmetics
Author: P. Elsner
Publisher: Springer Science & Business Media
Total Pages: 325
Release: 2012-12-06
Genre: Medical
ISBN: 3642598692

th Together with the 6 Amendment - Council Directive 93/35 EEC - to the Cosmetic Directive 76/768 EEC it was the first time that, according to Article 7b, special claims of efficacy could be legally attributed to cosmetic products but under the obligation to make evidence of the claimed effects; also an entirely new "controller" was introduced - the independent "safety assessor", This indeed means not only progress in reliable and honest marketing arguments but above all transparency as to the respective proof and thus protection of consumer's health. Such claims demand high standards in scientifi cally based methodology and their results in order to prove such demands evidently. There are also within the 6" Amendment to the Cosmetic Directive in Article 4a strict restrictions as to the further use of conventional animal testing for cosmetic pro ducts and their ingredients and especially for finished products. Without doubt there is a competition between the necessity and expectations on consumer health on the one hand and the requirements of acknowledged protection of animals as done in Council Directive 86/609 EEC on the other. But at least, based on the present state of knowledge, tests in human beings cannot replace animal testing in all instances. Not only ethical reasons alone prohibit or impede testing in humans but also very often the lack of knowledge on functional and/or biological processes underlaying observed effects with the consequence that suitable experimental methodologies are missing.

Mammalian Toxicology

Mammalian Toxicology
Author: Mohamed Abou-Donia
Publisher: John Wiley & Sons
Total Pages: 716
Release: 2015-05-04
Genre: Medical
ISBN: 1119940419

Mammalian Toxicology surveys chemical agents and examines how such chemicals impact on human health, emphasizing the importance in minimizing environmental exposure to chemical and physical hazards in our homes, communities and workplaces through such media as contaminated water, soil and air. Starting with the basic principles on a wide range of toxic agents, this textbook describes how they enter the body, their mechanisms of action once inside, and strategies for diagnosis, prevention and treatment. Topics covered include: General principles of toxicology: pharmacological and toxicological principles underpinning the study of toxicology, risk assessments and mechanisms of cell death Disposition: routes of chemical exposures, entry into the body and various tissues, storage, metabolic biotransformation and elimination, with examples from various toxicants. Toxic agents: the occurrences, disposition in the body, health effects, toxic mechanisms, antidotes and treatments of a range of agents including pesticides, metals, solvents, gases, nanomaterials, food components and additives, pharmaceuticals, drugs of abuse, natural toxins, endocrine disruptors, radiation, and warfare weapons. Toxic effects: including neurotoxicity, developmental toxicity, immunotoxicity, teratogenecity, male and female reproductive toxicity, mutagenecity, carcinogenicity, pulmonary toxicity, cardiovascular toxicity, hepatotoxicity, gastrointestinal toxicity and cardiovascular toxicity Toxicology and society: epidemiological studies of chemical-induced diseases in human populations, and a vision for toxicology in the 21st century. Mammalian Toxicology is an essential primer for students of toxicology, biochemistry, biology, medicine and chemistry. It is also appropriate for professional toxicologists in research or regulatory affairs, and anyone who needs to understand the adverse effects of toxic agents on the human body.

Code of Federal Regulations

Code of Federal Regulations
Author:
Publisher:
Total Pages: 612
Release: 2002
Genre: Administrative law
ISBN:

Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 1196
Release: 2009-06-17
Genre: Medical
ISBN: 0470464097

Drug Safety Evaluation Second Edition Shayne Cox Gad The updated and expanded safety guide to all aspects of the drug development process Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.