Drug Discovery And Clinical Research

Author by : SK Gupta
Languange : en
Publisher by : JP Medical Ltd
Format Available : PDF, ePub, Mobi
Total Read : 29
Total Download : 567
File Size : 42,5 Mb
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Description : The Drug Discovery and Clinical Research bandwagon has been joined by scientists and researchers from all fields including basic sciences, medical sciences, biophysicists, biotechnologists, statisticians, regulatory officials and many more. The joint effort and contribution from all is translating into the fast development of this multi-faceted field. At the same time, it has become challenging for all stakeholders to keep abreast with the explosion in information. The race for the finish-line leaves very little time for the researchers to update themselves and keep tabs on the latest developments in the industry. To meet these challenges, this book entitled Drug Discovery and Clinical Research has been compiled. All chapters have been written by stalwarts of the field who have their finger on the pulse of the industry. The aim of the book is to provide succinctly within one cover, an update on all aspects of this wide area. Although each of the chapter dealt here starting from drug discovery and development, clinical development, bioethics, medical devices, pharmacovigilance, data management, safety monitoring, patient recruitment, etc. are topics for full-fledged book in themselves, an effort has been made via this book to provide a bird’s eye view to readers and help them to keep abreast with the latest development despite constraints of time. It is hoped that the book will contribute to the growth of readers, which should translate into drug discovery and clinical research industry’s growth.


Clinical Research Drug Discovery Development

Author by : Neeru Agarwal
Languange : en
Publisher by : CreateSpace
Format Available : PDF, ePub, Mobi
Total Read : 75
Total Download : 329
File Size : 40,9 Mb
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Description : This comprehensive and well-organized text is grounded in real-world applications of theoretical concepts of Clinical Research with a primary focus on Drug development and clinical trial processes, Good Clinical Practices (GCP) guidelines, Drug regulatory affairs, Roles and responsibilities of various clinical trial stakeholders etc. A step by step guide for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. The text provides exemplary coverage of all the relevant issues. The definitive book on the subject


Drug Discovery And Evaluation Methods In Clinical Pharmacology

Author by : H.Gerhard Vogel
Languange : en
Publisher by : Springer Science & Business Media
Format Available : PDF, ePub, Mobi
Total Read : 28
Total Download : 905
File Size : 47,9 Mb
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Description : 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".


Drug Discovery And Development

Author by : Omboon Vallisuta
Languange : en
Publisher by : BoD – Books on Demand
Format Available : PDF, ePub, Mobi
Total Read : 94
Total Download : 665
File Size : 48,8 Mb
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Description : It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against Infectious Diseases; Advanced Methodology.


The Science And Business Of Drug Discovery

Author by : Edward D. Zanders
Languange : en
Publisher by : Springer Science & Business Media
Format Available : PDF, ePub, Mobi
Total Read : 32
Total Download : 261
File Size : 40,9 Mb
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Description : The Science and Business of Drug Discovery is written for those who want to learn about the biopharmaceutical industry and its products whatever their level of technical knowledge. Its aim is to demystify the jargon used in drug development, but in a way that avoids over simplification and the resulting loss of key information. Each of the nineteen chapters is illustrated with figures and tables which clarify some of the more technical points being made. Also included is a drug discovery case history which draws the relevant material together into a single chapter. In recognizing that it is difficult to navigate through the many external resources dealing with drug development, the book has been written to guide the reader towards the most appropriate information sources, including those listed in the two appendices. The following topics are covered: Different types of drugs: from small molecules to stem cells Background to chemistry of small and large molecules Historical background to drug discovery, pharmacology and biotechnology The drug discovery pipeline: from target discovery to marketed medicine Commercial aspects of drug discovery Challenges to the biopharmaceutical industry and its responses Material of specific interest to technology transfer executives, recruiters and pharmaceutical translators.


Pharmaceutical Biotechnology

Author by : Oliver Kayser
Languange : en
Publisher by : John Wiley & Sons
Format Available : PDF, ePub, Mobi
Total Read : 61
Total Download : 120
File Size : 42,9 Mb
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Description : This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.


New Drug Development

Author by : J. Rick Turner
Languange : en
Publisher by : Springer Science & Business Media
Format Available : PDF, ePub, Mobi
Total Read : 68
Total Download : 325
File Size : 47,9 Mb
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Description : New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.


Imaging In Drug Discovery And Early Clinical Trials

Author by : Markus Rudin
Languange : en
Publisher by : Springer Science & Business Media
Format Available : PDF, ePub, Mobi
Total Read : 67
Total Download : 527
File Size : 42,6 Mb
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Description : This monograph examines the contribution of imaging modalities to the stages of drug discovery and development, from early target validation to their use in clinical development programs. Chapters are devoted to the description of the drug discovery process, to the various imaging modalities preclinically and clinically, to applications of imaging during the optimization of a lead compound, addressing issues such as bioavailability and efficacy, and during drug safety evaluation.


Animal And Translational Models For Cns Drug Discovery Reward Deficit Disorders

Author by : Robert A. McArthur
Languange : en
Publisher by : Academic Press
Format Available : PDF, ePub, Mobi
Total Read : 65
Total Download : 326
File Size : 43,8 Mb
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Description : Reward Deficit Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for reward deficit disorders such as alcohol dependence, nicotine dependence, heroin and cocaine addiction, obesity, and gambling and impulse control disorders. Reward Deficit Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. Reward Deficit Disorders also has a section dedicated to the specifics of the regulatory aspects to abuse liability testing. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the third volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasizes what results mean to the overall drug discovery process Explores issues in clinical trial design and conductance in each therapeutic area Neurological Disorders is available for purchase individually.


Drug Discovery And Development Third Edition

Author by : James J. O'Donnell
Languange : en
Publisher by : CRC Press
Format Available : PDF, ePub, Mobi
Total Read : 97
Total Download : 156
File Size : 42,9 Mb
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Description : Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business