The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.
Facts101 is your complete guide to Drugs , From Discovery to Approval. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.
A case history approach to drug synthesis and discovery Discover the origins of some of today’s most popular drug therapies. Explore case histories and gain insight into major classes of antibiotics, antiviral drugs, analgesics, steroids, compounds designed to lower cholesterol, and more. Review the steps required for FDA approval. This is a great reference for students in medicinal chemistry, researchers in pharmaceuticals, and medical practitioners.
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.
Für Studierende und Wissenschaftler der Lebenswissenschaften schafft dieses Buch einen schnellen, strukturierten Zugang zur Angewandten Bioinformatik ohne Programmierkenntnisse oder tiefgehende Informatikkenntnisse vorauszusetzen. Es bietet eine Einführung in die tägliche Anwendung der vielfältigen bioinformatischen Werkzeuge und gibt einen ersten Überblick über das sehr komplexe Fachgebiet. Die Kontrolle des vermittelten Stoffs wird durch Übungsbeispiele mit Lösungen gewährleistet. Ein Glossar der zugrundeliegenden Fachtermini sowie ein ausführliches Sachverzeichnis runden das Buch ab. Für die 2. Auflage wurde das Werk umfassend aktualisiert.
It is the purpose and business of the pharmaceutical industry to dis cover, develop, and make available drugs for the care of the sick. The purpose of universities and national laboratories is to provide people and scientific knowledge that can help in the process. This book presents the combined efforts of scientists from the drug in dustry, academic laboratories and national laboratories to describe advances in radiotracer technology in studies on experimental ani mals and living human beings. The authors believe that the technol ogy is now ready for widespread application in the pharmaceutical industry. The goal of this book is to help bring this about. The field of Nuclear Medicine is based on the concept that, if treatment of disease is chemical, the patient's diagnosis should be chemical. Anatomy and histopathology have been the principle ba sis for making a diagnosis. Histopathologic data suffer from being descriptive, subjective, not quantifiable, and based on the study of dead tissue. The era of histopathology as the dominant concept in medical practice is coming to an end. Histopathologic findings are often heterogeneous and a single biopsy will at times not reveal the true nature of the disease, such as the grading of malignancy. Far greater accuracy of staging of disease and in the planning of treat ment is possible through chemistry, as well as by making possible a more suitable selection of a histological biopsy site.
In the fiercely competitive pharmaceutical marketplace, your organization cannot afford to spend excess dollars developing drugs that will fail to get FDA approval or have profoundly poor characteristics. Biochips as Pathways to Drug Discovery takes a comprehensive look at how the industry faces these challenges, using new technologies such as biochips to reduce the cost of drug discovery and improve drug safety. The book explores the tools and skills required at each step of the discovery process when using biochips to determine biological outcomes. The authors provide an in-depth review of the clinical and pharmacogenomic relevance of biochips, ChIP-chip assays, and high-throughput approaches. They discuss how biochips are used to develop biomarkers in the drug discovery process, primarily for gene expression profiling and Single Nucleotide Polymorphism (SNP) analysis. The book includes coverage of experimental theory, quality control, clinical laboratory sampling considerations, database concepts, industrial laboratory design, and the analysis of the resultant large data sets. It discusses the application of biochips to the study of malaria, toxicogenomics, and SNPs, as well as intellectual property and market overviews. The book concludes with a comprehensive overview of how these chips are employed from early target discovery through preclinical toxicology and on through to pharmacogenomic and proof of concept studies in humans. Written in an easily accessible style, the breadth of coverage introduces the subject to those new to the field, while the depth of coverage forms a foundation for future work. The book gives you the knowledge required to leverage the technology into bona fide discoveries. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.
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.
Fragment-based drug discovery is a rapidly evolving area of research, which has recently seen new applications in areas such as epigenetics, GPCRs and the identification of novel allosteric binding pockets. The first fragment-derived drug was recently approved for the treatment of melanoma. It is hoped that this approval is just the beginning of the many drugs yet to be discovered using this fascinating technique. This book is written from a Chemist's perspective and comprehensively assesses the impact of fragment-based drug discovery on a wide variety of areas of medicinal chemistry. It will prove to be an invaluable resource for medicinal chemists working in academia and industry, as well as anyone interested in novel drug discovery techniques.
The Process of New Drug Discovery and Development presents a practical methodology for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It includes detailed discussions regarding the research process and presents critiques of the governmental regulatory aspects of pharmaceutical research. The author also addresses the controversy surrounding the use of animals in biomedical research and provides current information regarding the field of biotechnology, international drug research, and registration activities. The Process of New Drug Discovery and Development is an excellent "how to" text for pharmaceutical researchers, oncologists, biochemists, experimental biologists, and others involved in new drug research and development.
New strategies and techniques for today's fast-paced discovery process Today, the pressure is on for high-throughput approaches to accelerate the generation, identification, and optimization of molecules with desirable drug properties. As traditional methods of analysis become antiquated, new analytical strategies and techniques are necessary to meet sample throughput requirements and manpower constraints. Among them, mass spectrometry has grown to be a front-line tool throughout drug discovery. Integrated Strategies for Drug Discovery Using Mass Spectrometry provides a thorough review of current analytical approaches, industry practices, and strategies in drug discovery. The topics represent current industry benchmarks in specific drug discovery activities that deal with proteomics, biomarker discovery, metabonomic approaches for toxicity screening, lead identification, compound libraries, quantitative bioanalytical support, biotransformation, reactive metabolite characterization, lead optimization, pharmaceutical property profiling, sample preparation strategies, and automation. THIS BOOK: * Clearly explains how drug discovery and mass spectrometry are interconnected * Discusses the uses and limitations of various types of mass spectrometry in various aspects of drug discovery * Prominently features analytical applications that require trace-mixture analysis * Provides industry applications and real-world examples * Shares historical background information on various techniques to aid in the understanding of how and why new methods are now being employed to analyze samples
The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries’ trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. New topic - DMPK Optimization Strategy in drug discovery. New chapter on Scaffolds: Small globular proteins as antibody substitutes. Totally updated chapters on Intellectual Property and Marketing 50 new illustrations in full colour Features Accessible, general guide to pharmaceutical research and development. Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. Written by a strong team of scientists with long experience in the pharmaceutical industry. Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: ‘... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. Highly Commended in the medicine category of the BMA 2006 medical book competition Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year
Studienarbeit aus dem Jahr 2010 im Fachbereich VWL - Finanzwissenschaft, Universität Bayreuth, Sprache: Deutsch, Abstract: Die vom Bundesministerim für Gesundheit ausgewiesenen Arzneimittelausgaben in der GKV verzeichneten in den letzten 10 Jahren einen nominalen Anstieg um 54,56 Prozent. Der Anteil an den Gesamtausgaben der GKV stieg in diesem Zeitraum von 14,52 auf 17,57 Prozent (vgl. BMG (2010), S. 1). Für das Jahr 2010 errechnete der Schätzerkreis der gesetzlichen Krankenversicherungen im Oktober 2009 eine Deckungslücke von 7,45 Milliarden Euro zwischen den Einnahmen und Ausgaben im Gesundheitsfond (vgl. BVA Schätzerkreis (2009). Zur Entlastung der Ausgabenseite in der GKV werden daher zahlreiche Maßnahmen u.a. im Bereich der Arzneimittelversorgung diskutiert. Im Fokus stehen dabei im Besonderen patentgeschützte Arzneimittel. Für diese Produkte konnte die Pharmaindustrie bisher die Preise, bis zum Erstattungshöchstbetrag, frei festsetzen. Neben der Kosten-Nutzen- Bewertung und weiteren Faktoren sollen nach der aktuellen Gesetzeslage bei der Festlegung des Erstattungshöchstbetrags auch die Entwicklungskosten von Medikamenten berücksichtigt werden (vgl. § 31 Abs. 2a SGB V).
One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.
Der beispiellose Absturz eines Start-up-Wunderkinds Elizabeth Holmes, Gründerin und CEO von Theranos, galt schnell als der weibliche Steve Jobs. Die Firma der 19-jährigen Blondine versprach, die Medizinindustrie mit einer Technologie zu revolutionieren, die Bluttests vereinfachen und Therapien gezielt steuern würde – eine Riesenhoffnung für Millionen von Menschen. Larry Ellison, Rupert Murdoch und andere Investoren steckten Unsummen in das Start-up, bis es mit neun Milliarden Dollar am Markt kapitalisiert war. Es gab nur ein einziges Problem: Die Technologie hinter den schicken Apparaturen hat nie funktioniert. Pulitzer-Preisträger John Carreyrou erzählt die packende Geschichte dieses Betrugs und seiner Enthüllung.
The health care and pharmacy environments have changed substantially since the first edition of this book. Developments include the new Medicare prescription benefit, a growing emphasis on medication safety, and the dynamic technology driving safety in organized health care settings. Exploring these recent modifications, Pharmacy: What It Is and How It Works, Second Edition encompasses all aspects of pharmacy, from the various roles of pharmacists to particular health care-related events to career-planning information. The book first focuses on the core of pharmacy, providing an overview of the field and a chapter dedicated to pharmacists. After an examination of how drug products are developed, used, and priced, it discusses the important topics of pharmacy technicians, information technology, pharmacy automation, and pharmaceutical care. Subsequent chapters cover the various areas where pharmacists work, including in community, hospital, home health care, and government pharmacies. The book concludes with chapters on the pharmaceutical industry and career planning. Each chapter features learning objectives, summaries, discussion questions, exercises, Web sites of interest, and references. Pharmacies have evolved from the corner drugstores of old. To help navigate the modern field of pharmacy, this text provides a well-written, organized introduction for new pharmacy students, pharmacy technician trainees, and practitioners.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. Every year, about 33,700 people in the United States will be diagnosed with pancreatic cancer and over 32,000 patients will die from the disease. The median survival of patients with advanced pancreatic cancer is about 6-months. This dismal picture of pancreatic cancer is mainly due to the lack of early diagnosis and effective treatment for patients with advanced disease. To increase the survival rate of pancreatic cancer patients, better tumor markers for diagnosis and new molecular targets for drug development are desperately needed. A lot of effort has been made in searching for pancreatic cancer-causing genes or genes associated with progression of malignant behavior in pancreatic cancer. As a result, alterations in the expression of several cancer-related genes have been identified in pancreatic tumors. The identification and characterization of these cancer-related genes have significantly increased our understanding of pancreatic cancer development, but unfortunately the treatment of pancreatic cancer has not advanced as much in the past 20 years. Over the past decade, tremendous advances have been made in the field of cancer drug discovery, particularly, in the area of molecular and genetic models and technologies. Many of those advanced models and technologies have been applied to the drug discovery processes for pancreatic cancer. In this book, a team of experts will describe the latest development in the application of these models and technologies in pancreatic cancer. The authors include basic researchers as well as clinicians who work in the front-line of the war against pancreatic cancer and have the first-hand experience on these cutting-edge tools and techniques. The book can be divided into two general areas: 1) model systems and 2) genomics and proteomics tools. In recent years there have been a lot of advances in the model systems for pancreatic cancer, including the further characterization of normal and cancerous pancreatic cell lines, the establishment of transgenic mouse models that recapitulate the initiation and progression of human pancreatic cancer, the development of a new xenograft model system for the evaluation of novel agents, and the establishment of a zebrafish pancreatic cancer model. The first four chapters of the book will be devoted to these models. The advances in genomics and proteomics research have made a major impact in cancer drug discovery. A number of these –omics-based tools and techniques have been applied in the pancreatic cancer drug discovery. Chapters 5-9 of the book will discuss techniques for genome-wide examination of gene expression, copy number, methylation, function and regulation. Chapters 10-11 will discuss in situ techniques for studying chromosomal and gene copy number abnormalities as well protein expression changes in cancer samples. Chapters 12-14 will focus on techniques for global examination of protein expression levels in biospecimens obtained from pancreatic cancer patients. Cancer drug discovery has become more and more target-centric.
The incorporation of Green Chemistry is a relatively new phenomenon in the drug discovery discipline, since the scale that chemists operate on in drug discovery is smaller than those of process and manufacturing chemistry. The necessary metrics are more difficult to obtain in drug discovery due to the diversity of reactions conducted. However, pharmaceutical companies are realizing that incorporation of green chemistry techniques at earlier stages of drug development can speed the development of a drug candidate. Written by experts who have pioneered green chemistry efforts within their own institutions, this book provides a practical guide for both academic and industrial labs wanting to know where to start with introducing greener approaches for greatest return on investment. The Editors have taken a comprehensive approach to the topic, covering the entire drug discovery process from molecule conception, through synthesis, formulation and toxicology with specific examples and case studies where green chemistry strategies have been implemented. Emerging techniques for performing greener drug discovery chemistry are addressed as well as cutting-edge topics like biologics discovery and continuous processing. Moreover, important surrounding issues such as intellectual property are included. This book serves as a practical guide for both academic and industrial chemists who work across the breadth of the drug discovery discipline. Ultimately, readers will learn how to incorporate green chemistry strategies into their everyday workflow without slowing down their science.
Die unglaubliche Geschichte einer Fälschung Die "jüdische Weltverschwörung" dient bis heute als Erklärung für jede nur erdenkliche Katastrophe: Kriege, Revolutionen, Wirtschaftskrisen, Börsenkräche, Terrorismus, Aids. Und immer wieder laufen die Fäden bei einem vermeintlich authentischen Buch zusammen: den "Protokollen der Weisen von Zion", deren Entstehungs- und Wirkungsgeschichte hier packend erzählt wird. 1934 kommt es in Bern zum Prozeß gegen die "Protokolle", den Ben-Itto anhand von Gerichtsakten und noch lebenden Zeugen rekonstruiert.