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Oecd Series On Testing And Assessment Guidance Document On Considerations For Waiving Or Bridging Of Mammalian Acute Toxicity Tests
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Book Synopsis OECD Series on Testing and Assessment Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests by : OECD
Download or read book OECD Series on Testing and Assessment Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests written by OECD and published by OECD Publishing. This book was released on 2017-04-13 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt: Acute toxicity tests are an area of focus for developing alternative assays and approaches to address animal welfare concerns. In the context of this document, acute toxicity studies refer to studies involving a single exposure to a test chemical and include those assessing systemic toxicity as ...
Book Synopsis OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment by : OECD
Download or read book OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment written by OECD and published by OECD Publishing. This book was released on 2017-04-13 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of ...
Book Synopsis Chemical Testing Using New Approach Methodologies (NAMs) by : Amy J. Clippinger
Download or read book Chemical Testing Using New Approach Methodologies (NAMs) written by Amy J. Clippinger and published by Frontiers Media SA. This book was released on 2022-12-16 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Nanocarriers for Drug Delivery by : Josimar O. Eloy
Download or read book Nanocarriers for Drug Delivery written by Josimar O. Eloy and published by Springer Nature. This book was released on 2021 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers basic aspects of different nanoparticles, including type of materials, lipid, polymeric and inorganic structures, synthesis strategies, as well as the main physicochemical characterization techniques. Moreover, this book addresses applications for both treatment and diagnosis of diseases, highlighting in vitro and in vivo findings and clinical evaluation. The chapters highlight the main barriers for drug delivery which can benefit from nanoencapsulation: the topical and oral routes. The main innovations in the field, such as gene therapy and functionalization of nanoparticles with a variety of moieties, including monoclonal antibodies for selective delivery, are discussed and illustrated with examples. Finally, the application of nanoparticles for drug delivery to cancer is reviewed considering toxicology and regulatory aspects.
Book Synopsis OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 402: Acute Dermal Toxicity by : OECD
Download or read book OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 402: Acute Dermal Toxicity written by OECD and published by OECD Publishing. This book was released on 2017-10-09 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt: This method provides information on health hazard likely to arise from a short-term exposure to solid or liquid test substance by the dermal route. This Test Guideline is intended primarily for use with rodents (rat, rabbit or guinea pig may be ...
Book Synopsis Alternative Toxicological Methods by : Harry Salem
Download or read book Alternative Toxicological Methods written by Harry Salem and published by CRC Press. This book was released on 2003-03-26 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Assessing Risks to Endangered and Threatened Species from Pesticides by : National Research Council
Download or read book Assessing Risks to Endangered and Threatened Species from Pesticides written by National Research Council and published by National Academies Press. This book was released on 2013-06-20 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: The US Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) are responsible for protecting species that are listed as endangered or threatened under the Endangered Species Act (ESA) and for protecting habitats that are critical for their survival. The US Environmental Protection Agency (EPA) is responsible for registering or reregistering pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and must ensure that pesticide use does not cause any unreasonable adverse effects on the environment, which is interpreted to include listed species and their critical habitats. The agencies have developed their own approaches to evaluating environmental risk, and their approaches differ because their legal mandates, responsibilities, institutional cultures, and expertise differ. Over the years, the agencies have tried to resolve their differences but have been unsuccessful in reaching a consensus regarding their assessment approaches. As a result, FWS, NMFS, EPA, and the US Department of Agriculture asked the National Research Council (NRC) to examine scientific and technical issues related to determining risks posed to listed species by pesticides. Specifically, the NRC was asked to evaluate methods for identifying the best scientific data available; to evaluate approaches for developing modeling assumptions; to identify authoritative geospatial information that might be used in risk assessments; to review approaches for characterizing sublethal, indirect, and cumulative effects; to assess the scientific information available for estimating effects of mixtures and inert ingredients; and to consider the use of uncertainty factors to account for gaps in data. Assessing Risks to Endangered and Threatened Species from Pesticides, which was prepared by the NRC Committee on Ecological Risk Assessment under FIFRA and ESA, is the response to that request.
Book Synopsis Dictionary of Pharmaceutical Medicine by : Gerhard Nahler
Download or read book Dictionary of Pharmaceutical Medicine written by Gerhard Nahler and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
Author :Organisation for Economic Co-operation and Development Publisher :Organisation for Economic Co-operation and Development ; [Montréal : Renouf] ISBN 13 :9789264122215 Total Pages : pages Book Rating :4.1/5 (222 download)
Book Synopsis OECD Guidelines for Testing of Chemicals by : Organisation for Economic Co-operation and Development
Download or read book OECD Guidelines for Testing of Chemicals written by Organisation for Economic Co-operation and Development and published by Organisation for Economic Co-operation and Development ; [Montréal : Renouf]. This book was released on 1981 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Drug Discovery and Evaluation: Methods in Clinical Pharmacology by : H.Gerhard Vogel
Download or read book Drug Discovery and Evaluation: Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".
Book Synopsis OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 420: Acute Oral Toxicity - Fixed Dose Procedure by : OECD
Download or read book OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 420: Acute Oral Toxicity - Fixed Dose Procedure written by OECD and published by OECD Publishing. This book was released on 2002-02-08 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt: A principle of the method is that in the main study only moderately toxic doses are used, and the administration of doses that are expected to be lethal should be avoided. This Guideline is intended primarily for use with rat. Groups of animals of a ...
Book Synopsis Nanotechnologies in Food by : Qasim Chaudhry
Download or read book Nanotechnologies in Food written by Qasim Chaudhry and published by Royal Society of Chemistry. This book was released on 2017-05-17 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanotechnologies in Food provides an overview of the products and applications of nanotechnologies in agri-food and related sectors. Following on from the success of the first edition, this new edition has been revised and updated to bring the reader fully up to date on the emerging technological, societal, and policy and regulatory aspects in relation to nanotechnologies in food. This book contains new chapters discussing some of the aspects that have attracted a lot of debate and research in recent years, such as how the regulatory definition of ‘nanomaterial’ is shaping up in Europe and whether it will result in a number of exciting food additives being regarded as nanomaterials, how the new analytical challenges posed by manufactured nanoparticles in food are being addressed and whether the emerging field of nano delivery systems for food ingredients and supplements, made of food materials or other soft/degradable polymers, can raise any consumer safety concerns. The edition concludes by discussing the future trends of the technological developments in the area of nanotechnologies and potential future ‘fusion’ with other fields, such as biotechnology and synthetic biology. This book provides a source of much needed and up-to-date information on the products and applications of nanotechnology for the food sector - for scientists, regulators, and consumers alike. It also gives an independent, balanced, and impartial view of the potential benefits as well as risks that nanotechnology applications may bring to the food sector. Whilst providing an overview of the state-of-the-art and foreseeable applications to highlight opportunities for innovation, the book also discusses areas of uncertainty in relation to public perception of the new technological developments, and potential implications for consumer safety and current regulatory controls. The book also discusses the likely public perceptions of nanotechnologies in the light of past technological developments in the food sector, and how the new technology will possibly be regulated under the existing regulatory frameworks.
Book Synopsis Genotoxicity and Carcinogenicity Testing of Pharmaceuticals by : Michael J. Graziano
Download or read book Genotoxicity and Carcinogenicity Testing of Pharmaceuticals written by Michael J. Graziano and published by Springer. This book was released on 2015-11-02 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
Book Synopsis The Textbook of Pharmaceutical Medicine by : John P. Griffin
Download or read book The Textbook of Pharmaceutical Medicine written by John P. Griffin and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 883 pages. Available in PDF, EPUB and Kindle. Book excerpt: New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia
Book Synopsis Microbicides for the Protection of Materials by : W. Paulus
Download or read book Microbicides for the Protection of Materials written by W. Paulus and published by Springer Science & Business Media. This book was released on 1993-09-30 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is chiefly intended for those who are using microbicides for the protection of materials. Another purpose is to inform teachers and students working on biodeterioration and to show today's technical standard to those engaged in R&D activities in the microbicide field. When trying to classify, or to subclassify, material-protecting microbicides according to their mode of action, e.g. as membrane-active and electrophilic active ingredients, it turned out that a clear assignment was not always possible. For that reason the author has resorted to chemistry's principle of classifying according to groups of substances (e.g. alcohols, aldehydes, ketones, acids, esters, amides, etc.), thus providing the first necessary information about the micro bicides' properties. The description of the various groups of substances includes, whenever possible, an outline of the mode and mechanism of action of the active ingredients involved. The effective use of microbicides presupposes knowledge of their character istics. That is why the microbicides' chemico-physical properties, their toxicity, ecotoxicity, effectiveness, and effective spectrum are described in greater detail. As mentioned before, the characteristics of microbicides play an important role. They have to be suited to the intended application to avoid detrimental effects on the properties and the quality of the material to be protected; also production processes in which microbicides are used to avoid disturbances by microbial action must not be disturbed by the presence of those microbicides.
Book Synopsis Dermatotoxicology Methods by : Francis N. Marzulli
Download or read book Dermatotoxicology Methods written by Francis N. Marzulli and published by CRC Press. This book was released on 2019-05-07 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work presents and evaluates methods employed to identify the potential of certain types of chemicals to adversely affect the skin. A variety of test methods are included such as tests for skin penetration, metabolism, irritation, the skin immune system, photo effects, skin cancer, and topical effects of retinoids and depigmenting chemicals. Tests for chemicals that affect the reproductive and nervous system are also included. Both animal and human tests that have been standardised and tests that are under development and employ animal alternatives are addressed in this book. Besides different testing methods, a rationale for accepting non-animal models and a review of some regulatory agency discussions about animal alternative tests are included.
Book Synopsis Alternatives to Animal Testing by : Michael Balls
Download or read book Alternatives to Animal Testing written by Michael Balls and published by Royal Society of Chemistry. This book was released on 2006 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal experimentation has long been a controversial issue with impassioned arguments on both sides of the debate. Increasingly it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved. Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics include; the safety evaluation of chemicals, international validation and barriers to the validation of alternative tests, in vitro testing for endocrine disruptors, intelligent approaches to safety evaluation of chemicals, alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate students wishing to pursue a career in the pharmaceutical and cosmetic industries.
