OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents PDF Download
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Author: OECD
Publisher: OECD Publishing
ISBN: 9264070729
Category :
Languages : en
Pages : 9
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Book Description
This method provides information on health hazard likely to arise from short-term exposure to test substance. The determination of sub-chronic oral toxicity using repeated doses may be carried out after initial information on toxicity has been ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070729
Category :
Languages : en
Pages : 9
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Book Description
This method provides information on health hazard likely to arise from short-term exposure to test substance. The determination of sub-chronic oral toxicity using repeated doses may be carried out after initial information on toxicity has been ...
Author: Organisation for Economic Co-operation and Development
Publisher: Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
ISBN: 9789264122215
Category : Chemical industry
Languages : en
Pages :
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Book Description
Author: OECD
Publisher: OECD Publishing
ISBN: 9264071229
Category :
Languages : en
Pages : 20
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Book Description
The objective of a combined chronic toxicity/carcinogenicity study is to identify carcinogenic and the majority of chronic effects, and to determine dose-response relationships following prolonged and repeated exposure. The rat is typically used for ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264071202
Category :
Languages : en
Pages : 18
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Book Description
The objective of these chronic toxicity studies is to characterize the profile of a substance in a mammalian species (primarily rodents) following prolonged and repeated exposure. The Test Guideline focuses on rodents and oral administration. Both ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264071180
Category :
Languages : en
Pages : 15
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Book Description
The objective of a long-term carcinogenicity study is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of ...
Author:
Publisher:
ISBN:
Category : Halocarbons
Languages : en
Pages : 120
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Book Description
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1119551218
Category : Medical
Languages : en
Pages : 548
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Book Description
Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
Author: Franz J. Hock
Publisher: Springer Nature
ISBN: 3031355296
Category : Medical
Languages : en
Pages : 2751
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Book Description
Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This "sequential" strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the 'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. The book is essential for scientists and managers in the pharmaceutical industry who are involved in drug discovery, drug development and decision making in the development process. In particular, the book will be of use to government institutions and committees working on official guidelines for drug evaluation worldwide.
Author: Ram Lakhan Singh
Publisher: Academic Press
ISBN: 0128163348
Category : Medical
Languages : en
Pages : 405
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Book Description
Despite advances in hygiene, food treatment, and food processing, diseases caused by foodborne pathogens continue to constitute a worldwide public health concern. Ensuring food safety to protect public health remains a significant challenge in both developing and developed nations. Food Safety and Human Health provides a framework to manage food safety risks and assure a safe food system. Political, economic, and ecological changes have led to the re-emergence of many foodborne pathogens. The globalization of food markets, for example, has increased the challenge to manage the microbial risks. This reference will help to identify potential new approaches in the development of new microbiologically safe foods that will aid in preventing food borne illness outbreaks and provides the basic principles of food toxicology, food processing, and food safety. Food Safety and Human Health is an essential resource to help students, researchers, and industry professionals understand and address day-to-day problems regarding food contamination and safety. - Encompasses the first pedagogic treatment of the entire range of toxic compounds found naturally in foods or introduced by industrial contaminatio - Identifies areas of vital concern to consumers, such as toxicological implications of food, and human health implications of food processing - Focuses on safety aspects of genetically modified foods and the range of processing techniques along with the important food safety laws
Author: OECD
Publisher: OECD Publishing
ISBN: 9264070966
Category :
Languages : en
Pages : 10
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Book Description
The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 54 days. This Test Guideline is designed ...
