| Description |
1 online resource : illustrations |
| Series |
Springer reference |
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Springer reference.
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| Contents |
Part 1. Safety Pharmacology. Safety Pharmacology: Introduction / Franz J. Hock -- Status of Safety Pharmacology and Present Guidelines / Franz J. Hock -- Central Nervous System (CNS) Safety Pharmacology Studies / Vincent Castagné [and others] -- Methods in Cardiovascular Safety Pharmacology / Pascal Champeroux [and others] -- Renal System in Safety Pharmacology / Susan G. Emeigh Hart -- Respiratory Function Assays in Safety Pharmacology / Dennis J. Murphy -- Safety Pharmacology in Metabolism Pharmacology / Andreas W. Herling -- Peripheral Nervous System / H. Gerhard Vogel -- Safety of Intravenous and Inhalation Anesthetics / Lars Arendt-Nielsen -- Drug-Addiction and Drug-Dependency / Charles P. France -- Blood Constituents and Safety Pharmacology / Shaker A. Mousa -- Ocular Safety Tests / Beat P. Mertz -- Side Effects of Central Analgesic Drugs / Lars Arendt-Nielsen -- Endocrine Pharmacology / Jürgen Sandow -- Skin Pharmacology / Thais H. Sakuma, / Hongbo Zhai, / Howard Maibach -- Safety Pharmacology Assessment of Biopharmaceuticals / Hamid R. Amouzadeh, / Hugo M. Vargas -- Magnetic Resonance Imaging in Pharmaceutical Safety Assessment / Paul D. Hockings -- Oncology Pharmacology / Jason H. Gill PhD -- Transgenic Animals / Will S. Redfern, / Jean-Pierre Valentin -- Zebrafish in Drug Discovery: Safety Assessment / Adrian Hill Chronobiology and the Implications for Safety Pharmacology / Björn Lemmer, / Maxim Soloviev -- Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic Acids, and Mammalian Cells / Larry R. Brown -- Nanotechnology and Safety Pharmacology / A. Michael Bloh -- Safe Chemicals/REACH / Thomas Rücker -- Study Design and Statistics / S.W. Mittelstadt |
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Part 2. Pharmacokinetics. Safety Pharmacokinetics: Introduction / Jochen Maas -- Absorption: In Vitro Tests -- Cell Based / Katharina Mertsch -- Absorption: In Vitro Tests -- Non Cell Based / Markus Kohlmann -- Absorption: In Vivo Tests (Radiolabeled) / Volker Krone -- Bioanalytical Assays: Gas Chromatography (GC) / Dietmar Schmidt -- Bioanalytical Assays LC-MS/MS / Joern Krause, / Ronald Schmidt -- Bioanalytical Assays: RIA/EIA / Heinz Jürgen Skrzipczyk, / Patrick Verdier -- Bioanalytical Assays -- Toxicokinetics / Karl-Heinz Lehr -- Distribution -- In Vitro Tests -- Protein Binding / Jens Riedel -- Distribution -- In Vivo -- Perfused Organs / Andreas W. Herling -- Distribution: Across Barriers / Tanja Eisenblaetter [and others] -- Distribution In Vivo -- Distribution In Vivo: Other Methods / Yves Archimbaud -- Drug-Drug Interaction: Enzyme Induction / Peter Bünning -- Drug-Drug Interaction: Enzyme Inhibition / Angela Dudda, / Gert Ulrich Kuerzel In-Silico ADME Modeling / Hans Matter, / Wolfgang Schmider -- Metabolism Studies In Vitro and In Vivo / Angela Dudda, / Gert Ulrich Kuerzel -- Pharmacogenomics in Drug Metabolizing Enzymes and Transporters / Jochen Maas, / Roland Wesch, / Dietmar Weitz -- Physicochemical Properties / Heiko Tietgen, / Michael Walden -- Clinical Pharmacokinetic Studies / Axel Steinstraesser, / Roland Wesch, / Annke Frick -- Population Pharmacokinetics / Willi Weber, / Diether Rüppel -- Typical PK/PD Approaches in Preclinical and Clinical Development / Willi Weber |
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Part 3. Safety Toxicology. Safety Toxicology: Introduction / Dieter Mayer -- International Guidelines / Gerd Bode -- Testing of Medical Devices / Felix Chevalier -- In Silico Methods / Alexander Amberg -- Genotoxicity / Ingo Stammberger, / Andreas Czich, / Knut Braun -- Reproductive Toxicology / Thomas Hofmann -- In Vitro Toxicology / Mostafa Kabiri -- OMICS Technologies / Christina S. Schmitt [and others] |
| Summary |
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 |
| Analysis |
farmacologie |
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pharmacology |
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toxicologie |
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toxicology |
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biomedische wetenschappen |
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biomedicine |
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Medicine (General) |
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Geneeskunde (algemeen) |
| Bibliography |
Includes bibliographical references and index |
| Notes |
English |
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Print version record |
| Subject |
Pharmacology, Experimental.
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Drugs -- Design.
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Drugs -- Testing.
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Pharmacokinetics.
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Chemistry, Pharmaceutical -- methods
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Drug Design
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Drug Evaluation, Preclinical
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Pharmacokinetics
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Pharmacokinetics
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Drugs -- Design
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Drugs -- Testing
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Pharmacology, Experimental
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| Form |
Electronic book
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| Author |
Vogel, H. Gerhard, 1927-
|
| ISBN |
9783642252402 |
|
3642252400 |
|
