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Taschenbuch. Zustand: Neu. Cardiac Drug Development Guide | Michael K. Pugsley | Taschenbuch | Methods in Pharmacology and Toxicology | x | Englisch | 2013 | Humana | EAN 9781489938282 | Verantwortliche Person für die EU: Humana Press in Springer Science + Business Media, Heidelberger Platz 3, 14197 Berlin, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
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Zustand: New. Editor(s): Pugsley, Michael K. Series: Methods in Pharmacology and Toxicology. Num Pages: 441 pages, biography. BIC Classification: MQP. Category: (P) Professional & Vocational. Dimension: 254 x 178 x 23. Weight in Grams: 839. . 2013. Softcover reprint of the original 1st ed. 2003. Paperback. . . . . Books ship from the US and Ireland.
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In den WarenkorbHardcover. Zustand: Brand New. 1st edition. 347 pages. 9.25x7.50x1.00 inches. In Stock.
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Zustand: New. Editor(s): Pugsley, Michael K. Series: Methods in Pharmacology and Toxicology. Num Pages: 431 pages, biography. BIC Classification: GB; MMG. Category: (P) Professional & Vocational; (UP) Postgraduate, Research & Scholarly; (UU) Undergraduate. Dimension: 254 x 178 x 25. Weight in Grams: 984. . 2003. Hardback. . . . . Books ship from the US and Ireland.
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Taschenbuch. Zustand: Neu. Principles of Safety Pharmacology | Michael K. Pugsley (u. a.) | Taschenbuch | viii | Englisch | 2016 | Springer | EAN 9783662520963 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
Sprache: Englisch
Verlag: Springer Berlin Heidelberg, Springer Berlin Heidelberg, 2016
ISBN 10: 3662520966 ISBN 13: 9783662520963
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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.
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Buch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.
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Sprache: Englisch
Verlag: Springer International Publishing, Springer International Publishing, 2024
ISBN 10: 3031355288 ISBN 13: 9783031355288
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In den WarenkorbBuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - 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.&nb.