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  • 1
    Berlin, Heielberg : Springer
    Keywords: Medicine ; Toxicology ; Chemicals / Safety measures ; Medicine, Industrial ; Biomedicine ; Pharmacology/Toxicology ; Occupational Medicine/Industrial Medicine ; Biomedicine general ; Safety in Chemistry, Dangerous Goods ; Springer eBooks
    Description / Table of Contents: Foreword -- Introduction -- Operation mode of regulatory toxicology -- Aims and institutions -- Aims and mission -- Application areas -- National and international collaboration -- Procedures and standards -- The regulatory process -- Quality assurance in regulatory toxcicology -- Toxicological risk assessment -- Methodological repertoire -- Toxicological tests -- Characterization of physicochemical parameters -- Examination of acute and chronic toxicity -- Examination of organ-toxicity and of laboratory parameters -- Specific tests for neurotox , immunotox, allergy, irritation, reprotox and carcinogenicity -- Toxicity testing in vitro -- New and future toxicological assays -- Computer-based prediction models -- Metabolism tests -- Toxicokinetic tests -- Toxicodynamic tests -- Omics -- International regulation for toxicological test procedures -- Data acquisition in humans -- Epidemiological methods -- Studies in volunteers -- Chemical analysis in toxicology (New) -- Toxicostatistics and models -- Statistical evaluation methods -- Dose-response analysis, identification of threshold levels -- Extrapolation-procedures for carcinogenic and non-carcinogenic compounds -- Probabilistic methods -- Toxicodynamic models -- Toxicokinetic models -- Estimation of exposure -- Exposure analysis for indoor contaminants -- Exposure scenarios -- Use of toxiological data -- Quality criteria for primary literature -- Data-mining -- Paradigms use in risk evaluation -- Toxicological paradigms -- Do carcinogens have a threshold dose? pro and contra -- Single compounds vs combination effects -- Biomolecules vs smaller chemicals -- Sensitive humans vs average persons -- Assessment paradigmas -- Extrapolation factors and safety factors -- Background exposure vs additional exposure in human biomonitoring -- Adverse effects vs non-adverse effects -- ADI vs MOS principle -- Precaution principle vs hazard control -- Hygienic vs toxicological approaches -- Protected property and protection level -- Risk characterization and risk evaluation -- The risk concept -- Current℗ role of the term "risk" -- Risk cycles -- Risk minimization in drug development -- Data required for risk evaluation -- Importance of physical-chemical properties -- Importance of intrinsic toxic properties -- Importance of metabolism and of mechanism of action -- Importance of the extrapolation to lower doses in risk assessment -- Importance of exposure level for risk assessment -- Risk characterization -- Risk assessment -- Elements of risk assessment -- Risk comparison -- Risk-benefit considerations -- Risk assessment in different jurisdictions -- Reach as a regulatory instrument (New) -- Risk management and risk communication -- Risk management -- Purpose of risk management -- Assessment of limit values -- Deduction of limit values in different areas -- Registration and approval -- Classification and labelling -- Monitoring unwanted exposures and effects -- Restrictions and prohibitions -- Observance of susceptible population groups -- The toxicological expert report -- Risk management in toxicological emergencies -- Risk communication and participation of affected people -- Institutionalized participation -- The technique of risk communication -- Dealing with diseases that have been attributed to chemical exposures -- Addendum: tables and lists -- Checklist: Toxicological risk assessment in practice -- Glossary and risk terms -- Limit values, guideline values, tables -- Proposed additional chapters on℗ Ethics in toxicology and expansion of the chapter dealing with℗ Immunotoxicology
    Abstract: This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004.℗ Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference
    Pages: XXIV, 946 p. 144 illus., 70 illus. in color. eReference. : online resource.
    ISBN: 9783642353741
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  • 2
    Call number: Z070:250
    Pages: 414 p. : ill.
    Edition: 20., aktual. und erw. Aufl. 2010
    ISBN: 978-3-481-02614-1
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    Z070:250 departmental collection or stack – please contact the library
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  • 3
    Call number: 0112:2
    Keywords: Animals, Domestic / anatomy ; Anatomie / Atlas ; Haustier / Anatomie
    Pages: 265 p. : ill.
    ISBN: 3-432-29191-4
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    0112:2 departmental collection or stack – please contact the library
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  • 4
    Call number: 2020:98
    Keywords: Tier / Versuch
    Pages: 352 p. : ill.
    ISBN: 3-86025-195-3
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    2020:98 departmental collection or stack – please contact the library
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  • 5
    Call number: 08-Allg
    Keywords: Total Quality Management
    Pages: xvii, 324 p. : ill.
    Edition: 2., erw. Aufl.
    ISBN: 3-446-21118-7
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  • 6
    Call number: YY Diss Fran/Mag
    Keywords: DKFZ-publications / academic dissertations
    Pages: 68 p.
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  • 7
    Keywords: Medicine ; Toxicology ; Biomedicine ; Pharmacology/Toxicology ; Springer eBooks
    Description / Table of Contents: From the contents:General Introduction: Safety Pharmacology -- Safety Pharmacokinetics -- Safety Toxicology
    Abstract: Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails. But 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. A change of strategy was therefore adopted, involving the following changes: -℗ ℗ ℗ ℗ ℗ ℗ ℗ ℗ ℗ 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. Easily accessible and the most informative tests now have to be selected.-℗ ℗ ℗ ℗ ℗ ℗ ℗ ℗ ℗ Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development. Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics.The book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs.The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide
    Pages: : digital.
    ISBN: 9783642252402
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  • 8
    Keywords: Medicine ; Nephrology ; Pediatrics ; Medicine & Public Health ; Pediatrics ; Nephrology ; Springer eBooks
    Edition: 2nd ed.
    ISBN: 9781461407218
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  • 9
    Call number: WN440:30(4)
    Keywords: Nuclear Medicine / instrumentation ; Quality Control
    Pages: x, 287 p. : ill.
    Edition: 4., überarb. Aufl.
    ISBN: 9783708914121
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    WN440:30(4) on loan
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  • 10
    Keywords: Toxicology ; Pharmacy ; Biochemistry ; Pharmacology/Toxicology ; Pharmacy ; Biochemistry, general ; Springer Nature Living Reference
    Abstract: The rapid progress in biology will continue to change the methodological approach to drug discovery in the coming years. Electronic media will continuously help researchers to access and share information. It is, however, becoming more and more evident that many young pharmacologists have only limited training in classical pharmacological methodologies. These long-standing and still highly relevant methods are simply not available in the electronic databases. Drug Discovery and Evaluation:Pharmacological Assays bridges this gap by comprehensively covering the pharmacological methods that have been utilized successfully for more than a hundred years as well as the latest technologies. The classical methods and the newest technologies, all in one book! The 3rd edition of this successful reference book contains an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Effects covered include cardiovascular, analgesic, endocrine, psychotropic, respiratory, renal, and immunomodulatory activities. Each of the more than 1000 assays comprises a detailed protocol outlining the purpose and rationale of the method, a critical assessment of the results and their pharmacological and clinical relevance. In addition, animal models of rare diseases are described. For this third edition, all existing chapters have been revised and completely updated. A large number of assays were added: we are now publishing two volumes. Sections that have been specifically enlarged include - Pharmacological assays in thrombosis and haemostasis (formerly called activity of blood constituents), - Antidiabetic activity (includes completely new chapters such as Biochemical Methods in Diabetology), - Anti-atherosclerotic activity. Audience: Pharmacologists and Pharmacists in Academia and Industry
    Pages: LVIII, 2071 p. 5 illus. : online resource.
    ISBN: 9783642277283
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