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Book
Drug discovery and evaluation : methods in clinical pharmacology
Authors: --- ---
ISBN: 3540898905 3540898913 3540898921 Year: 2011 Publisher: New York : Springer,

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Abstract

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".


Digital
Drug Discovery and Evaluation: Methods in Clinical Pharmacology
Authors: --- ---
ISBN: 9783540898917 Year: 2011 Publisher: Berlin, Heidelberg Springer Berlin Heidelberg

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Authors: --- --- ---
ISBN: 3540256385 9783540256380 3540298045 3540334424 Year: 2006 Publisher: Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer,

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Keywords

Biopharmaco-efficiency. Pharmacokinetics --- Pharmacosynthesis. Pharmacochemistry --- Pharmacology, Experimental --- Drugs --- Pharmacologie expérimentale --- Médicaments --- Design --- Testing --- Conception --- Essais cliniques --- Drug development. --- Drugs -- Research. --- Drugs -- Safety measures. --- Electronic books. -- local. --- Pharmacokinetics. --- Chemistry, Pharmaceutical --- Pharmacokinetics --- Drug Design --- Drug Evaluation, Preclinical --- Drug Discovery --- Chemistry --- Metabolic Phenomena --- Pharmacology --- Evaluation Studies as Topic --- Pharmacological Phenomena --- Kinetics --- Physiological Phenomena --- Investigative Techniques --- Biochemical Phenomena --- Natural Science Disciplines --- Phenomena and Processes --- Biological Science Disciplines --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Chemical Phenomena --- Disciplines and Occupations --- Pharmacy, Therapeutics, & Pharmacology --- Health & Biological Sciences --- Research. --- Safety measures. --- Pharmacologie expérimentale --- Médicaments --- EPUB-LIV-FT LIVBIOMO LIVMEDEC SPRINGER-B --- Drug kinetics --- Kinetics, Drugs --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Pharmaceutical research --- Development of drugs --- New drug development --- Research --- Development --- Medicine. --- Pharmacology. --- Biomedicine. --- Pharmacology/Toxicology. --- Chemical kinetics --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacy --- Metabolism --- Toxicology. --- Chemicals --- Medicine --- Poisoning --- Poisons --- Toxicology --- Drug effects --- Medical pharmacology --- Medical sciences --- Physiological effect --- Pharmacology, Experimental. --- Experimental pharmacology --- Therapeutics, Experimental


Book
Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Authors: --- --- ---
ISBN: 3642252397 3642252400 3642252419 Year: 2013 Publisher: Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer,

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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.


Book
Drug Discovery and Evaluation: Methods in Clinical Pharmacology
Authors: --- --- ---
ISBN: 9783540898917 Year: 2011 Publisher: Berlin Heidelberg Springer Berlin Heidelberg

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Abstract

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 žSafety 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: žMethods in Clinical Pharmacology".


Digital
Drug Discovery and Evaluation : Safety and Pharmacokinetic Assays
Authors: --- --- ---
ISBN: 9783540298045 Year: 2006

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Abstract


Digital
Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Authors: --- --- ---
ISBN: 9783642252402 Year: 2013 Publisher: Berlin, Heidelberg Springer

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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.


Book
Drug Discovery and Evaluation : Safety and Pharmacokinetic Assays
Authors: --- --- --- ---
ISBN: 9783540298045 Year: 2006 Publisher: Berlin Heidelberg Springer Berlin Heidelberg

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Abstract

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