Screen LibraryDrug discovery and evaluation : safety and pharmacokinetic assays /
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...
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| Corporate Authors: | |
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| Published: |
Springer,
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| Publisher Address: | Berlin ; New York : |
| Publication Dates: | 2013. |
| Literature type: | eBook |
| Language: | English |
| Edition: | Second edition. |
| Series: |
Springer reference
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| Subjects: | |
| Online Access: |
http://dx.doi.org/10.1007/978-3-642-25240-2 |
| 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, a |
| Carrier Form: | 1 online resource : ill. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9783642252402 (electronic bk.) 3642252400 (electronic bk.) |
| Index Number: | RM301 |
| CLC: | R914 |
| Contents: |
Safety Pharmacology. Safety Pharmacology: Introduction / Status of Safety Pharmacology and Present Guidelines / Central Nervous System (CNS) Safety Pharmacology Studies / Methods in Cardiovascular Safety Pharmacology / Renal System in Safety Pharmacology / Respiratory Function Assays in Safety Pharmacology / Safety Pharmacology in Metabolism Pharmacology / Peripheral Nervous System / Safety of Intravenous and Inhalation Anesthetics / Drug-Addiction and Drug-Dependency / Blood Constituents and Safety Pharmacology / Ocular Safety Tests / Side Effects of Central Analgesic Drugs / Endocrine Pharmacology / Skin Pharmacology / Safety Pharmacology Assessment of Biopharmaceuticals / Magnetic Resonance Imaging in Pharmaceutical Safety Assessment / Oncology Pharmacology / Transgenic Animals / Zebrafish in Drug Discovery: Safety Assessment / Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic Acids, and Mammalian Cells / Nanotechnology and Safety Pharmacology / Safe Chemicals/REACH / Study Design and Statistics / Pharmacokinetics. Safety Pharmacokinetics: Introduction / Absorption: In Vitro Tests - Cell Based / Absorption: In Vitro Tests - Non Cell Based / Absorption: In Vivo Tests (Radiolabeled) / Bioanalytical Assays: Gas Chromatography (GC) / Bioanalytical Assays LC-MS/MS / Bioanalytical Assays: RIA/EIA / Bioanalytical Assays - Toxicokinetics / Distribution - In Vitro Tests - Protein Binding / Distribution - In Vivo - Perfused Organs / Distribution: Across Barriers / Distribution In Vivo -- Distribution In Vivo: Other Methods / Drug-Drug Interaction: Enzyme Induction / Drug-Drug Interaction: Enzyme Inhibition / Metabolism Studies In Vitro and In Vivo / Pharmacogenomics in Drug Metabolizing Enzymes and Transporters / Physicochemical Properties / Clinical Pharmacokinetic Studies / Population Pharmacokinetics / Typical PK/PD Approaches in Preclinical and Clinical Development / Safety Toxicology. Safety Toxicology: Introduction / International Guidelines / Testing of Medical Devices / In Silico Methods / Genotoxicity / Reproductive Toxicology / In Vitro Toxicology / OMICS Technologies / |