Overcoming Obstacles In Drug Discovery And Development
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Overcoming Obstacles In Drug Discovery And Development
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Author : Kan He
language : en
Publisher: Elsevier
Release Date : 2023-05-18
Overcoming Obstacles In Drug Discovery And Development written by Kan He and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-18 with Medical categories.
Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development. Provides real-world case studies in drug discovery and the development of drugs Illustrates the use of critical thinking and problem solving in approaching preclinical and clinical problems in drug discovery and development Illustrates and analyses examples of successes and failures in drug discovery and development that have not previously been reported
Overcoming Obstacles In Drug Discovery And Development
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Author : Kan He
language : en
Publisher: Elsevier
Release Date : 2023-03
Overcoming Obstacles In Drug Discovery And Development written by Kan He and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03 with Business & Economics categories.
Overcoming Obstacles in Drug Discovery and Development: Surmounting the Insurmountable uses real-world case studies to illustrate how critical thinking and problem-solving skills are applied and necessary in the discovery and development of drugs. The book shows how the development of critical thinking to overcome issues plays an essential role in scientific and professional expertise. As addressing critical, unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills, this book is an ideal training manual on how to overcome obstacles. It will be essential to young scientists who want to develop the skills to successfully face challenges, learn from their mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from case studies of successful and unsuccessful drug development Provides real-world case studies in drug discovery and the development of drugs Illustrates the use of critical thinking and problem-solving in approaching preclinical and clinical problems in drug discovery and development Analyzes examples of successes and failures in drug discovery and development that have not previously been reported
Drug Discovery And Development
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Author : Raymond G Hill
language : en
Publisher: Elsevier Health Sciences
Release Date : 2021-05-16
Drug Discovery And Development written by Raymond G Hill and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-05-16 with Medical categories.
With unprecedented interest in the power that the modern therapeutic armamentarium has to combat disease, the new edition of Drug Discovery and Development is an essential resource for anyone interested in understanding how drugs and other therapeutic interventions are discovered and developed, through to clinical research, registration, and market access. The text has been thoroughly updated, with new information on biopharmaceuticals and vaccines as well as clinical development and target identification. Drug discovery and development continues to evolve rapidly and this new edition reflects important changes in the landscape. Edited by industry experts Raymond Hill and Duncan Richards, this market-leading text is suitable for undergraduates and graduates undertaking degrees in pharmacy, pharmacology, toxicology, and clinical development through to those embarking on a career in the pharmaceutical industry. Key stages of drug discovery and development Chapters outline the contribution of individual disciplines to the overall process Supplemented by specific chapters on different modalities Includes coverage of Oligonucleotide therapies; cell and gene therapy Now comes with online access on StudentConsult
Challenges For The Fda
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-11-02
Challenges For The Fda written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-02 with Medical categories.
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.
Introduction To Biological And Small Molecule Drug Research And Development
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Author : C. Robin Ganellin
language : en
Publisher: Academic Press
Release Date : 2013-05-07
Introduction To Biological And Small Molecule Drug Research And Development written by C. Robin Ganellin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-07 with Science categories.
Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development
The Science And Business Of Drug Discovery
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Author : Edward D. Zanders
language : en
Publisher: Springer Nature
Release Date : 2020-11-09
The Science And Business Of Drug Discovery written by Edward D. Zanders and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-09 with Medical categories.
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 twenty 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
Drug Discovery And Development Third Edition
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Author : James J. O'Donnell
language : en
Publisher: CRC Press
Release Date : 2019-11-21
Drug Discovery And Development Third Edition written by James J. O'Donnell and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-21 with Medical categories.
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
Case Studies In Modern Drug Discovery And Development
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Author : Xianhai Huang
language : en
Publisher: John Wiley & Sons
Release Date : 2012-04-19
Case Studies In Modern Drug Discovery And Development written by Xianhai Huang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-19 with Medical categories.
Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.
The Process Of New Drug Discovery And Development
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Author : G. Smith Charles
language : en
Publisher: CRC Press
Release Date : 1992-08-24
The Process Of New Drug Discovery And Development written by G. Smith Charles and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992-08-24 with Medical categories.
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.
Accelerating The Development Of New Drugs And Diagnostics
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-11-23
Accelerating The Development Of New Drugs And Diagnostics written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-23 with Medical categories.
Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfully developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cures Acceleration Network (CAN)-a part of the National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH)-has the potential to catalyze widespread changes in NCATS, NIH, and the drug development ecosystem in general. On June 4-5, 2012, the IOM Forum on Drug Discovery, Development, and Translation held, at the request of NCATS, a workshop-bringing together members of federal government agencies, the private sector, academia, and advocacy groups-to explore options and opportunities in the implementation of CAN. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary summarizes the workshop.