Overcoming Obstacles In Drug Discovery And Development

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Overcoming Obstacles in Drug Discovery and Development

Kan He,Paul F. Hollenberg,Larry C. Wienkers
Overcoming Obstacles in Drug Discovery and Development Book PDF

Author : Kan He,Paul F. Hollenberg,Larry C. Wienkers
Publisher : Elsevier
Page : 448 pages
File Size : 52,5 Mb
Release : 2023-05-18
Category : Medical
ISBN : 9780128173398

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Overcoming Obstacles in Drug Discovery and Development by Kan He,Paul F. Hollenberg,Larry C. Wienkers Pdf

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

Kan He,Paul F. Hollenberg,Larry C. Wienkers
Overcoming Obstacles in Drug Discovery and Development Book PDF

Author : Kan He,Paul F. Hollenberg,Larry C. Wienkers
Publisher : Elsevier
Page : 446 pages
File Size : 46,8 Mb
Release : 2023-03
Category : Business & Economics
ISBN : 9780128171349

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Overcoming Obstacles in Drug Discovery and Development by Kan He,Paul F. Hollenberg,Larry C. Wienkers Pdf

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

Raymond G Hill,Duncan Richards
Drug Discovery and Development Book PDF

Author : Raymond G Hill,Duncan Richards
Publisher : Elsevier Health Sciences
Page : 387 pages
File Size : 51,6 Mb
Release : 2021-05-16
Category : Medical
ISBN : 9780702078057

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Drug Discovery and Development by Raymond G Hill,Duncan Richards Pdf

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

Introduction to Biological and Small Molecule Drug Research and Development

C. Robin Ganellin,Roy Jefferis,Stanley M. Roberts
Introduction to Biological and Small Molecule Drug Research and Development Book PDF

Author : C. Robin Ganellin,Roy Jefferis,Stanley M. Roberts
Publisher : Academic Press
Page : 472 pages
File Size : 42,9 Mb
Release : 2013-05-07
Category : Science
ISBN : 9780123977700

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Introduction to Biological and Small Molecule Drug Research and Development by C. Robin Ganellin,Roy Jefferis,Stanley M. Roberts Pdf

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 Process of New Drug Discovery and Development

G. Smith Charles
The Process of New Drug Discovery and Development Book PDF

Author : G. Smith Charles
Publisher : CRC Press
Page : 166 pages
File Size : 53,7 Mb
Release : 1992-08-24
Category : Medical
ISBN : 0849342112

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The Process of New Drug Discovery and Development by G. Smith Charles Pdf

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.

Challenges for the FDA

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Challenges for the FDA Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 128 pages
File Size : 51,8 Mb
Release : 2007-10-02
Category : Medical
ISBN : 9780309179447

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Challenges for the FDA by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Drug Discovery and Development, Third Edition

James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Drug Discovery and Development Third Edition Book PDF

Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publisher : CRC Press
Page : 697 pages
File Size : 49,8 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9781351625142

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Drug Discovery and Development, Third Edition by James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell Pdf

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

Drug Discovery and Development : Prospects and Challenges

Muhammad Taher Bakhtiar
Drug Discovery and Development Prospects and Challenges Book PDF

Author : Muhammad Taher Bakhtiar
Publisher : IIUM PRESS
Page : 64 pages
File Size : 47,7 Mb
Release : 2021-08-11
Category : Fiction
ISBN : 9789674911546

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Drug Discovery and Development : Prospects and Challenges by Muhammad Taher Bakhtiar Pdf

This book is written to provide a brief overview concerning the latest drug discovery and its development based on the research studies that have been carried out until the present. The idea of preparing this book was inspired by the Holy Qur’an and the hadith, which guides us in all aspects of life, including disease management and treatment. This was supported by the traditional use of natural medicine by our ancestors. From the scientific point of view, we translate all those knowledge and information to be evidence-based modern medicines. We practised the common process of drug discovery development by identifying the potential molecule, followed by in vitro and in vivo experiments. The formulation is a crucial process to produce an efficient and effective drug delivery. Not to forget the future vision that “things would not give any meaning if it is not giving benefit to the people”. Commercialisation is one of the approaches to promote the product across the market and community. The book ends with the current issue of the COVID-19 global pandemic with regards to the treatment, natural medicine, and vaccination.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Improving and Accelerating Therapeutic Development for Nervous System Disorders Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 107 pages
File Size : 55,5 Mb
Release : 2014-02-06
Category : Medical
ISBN : 9780309292498

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Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Guide to Drug Development

Bert Spilker
Guide to Drug Development Book PDF

Author : Bert Spilker
Publisher : Lippincott Williams & Wilkins
Page : 1277 pages
File Size : 43,9 Mb
Release : 2009
Category : Business & Economics
ISBN : 0781774241

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Guide to Drug Development by Bert Spilker Pdf

Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

Applications of Artificial Intelligence in Healthcare and Biomedicine

Abdulhamit Subasi
Applications of Artificial Intelligence in Healthcare and Biomedicine Book PDF

Author : Abdulhamit Subasi
Publisher : Elsevier
Page : 550 pages
File Size : 55,8 Mb
Release : 2024-03-22
Category : Computers
ISBN : 9780443223099

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Applications of Artificial Intelligence in Healthcare and Biomedicine by Abdulhamit Subasi Pdf

??Applications of Artificial Intelligence in Healthcare and Biomedicine provides ?updated knowledge on the applications of artificial intelligence in medical image analysis. The book starts with an introduction to Artificial Intelligence techniques for Healthcare and Biomedicine. In 16 chapters it presents artificial applications in Electrocardiogram (ECG), Electroencephalogram (EEG) and Electromyography (EMG), signal analysis, Computed Tomography (CT), Magnetic Resonance Imaging (MR) and Ultrasound image analysis. It equips researchers with tools for early breast cancer detection from mammograms using artificial intelligence (AI), AI models to detect lung cancer using histopathological images and a deep learning-based approach to get a proper and faster diagnosis of the Optical Coherence Tomography (OCT) images. It also presents present 3D medical image analysis using 3D Convolutional Neural Networks (CNNs). Applications of Artificial Intelligence in Healthcare and Biomedicine closes with a chapter on AI-based approach to forecast diabetes patients' hospital re-admissions. This is a valuable resource for clinicians, researchers and healthcare professionals who are interested in learning more about the applications of Artificial Intelligence and its impact in medical/biomedical image analysis. Provides knowledge on Artificial Intelligence algorithms for clinical data analysis Gives insights into both AI applications in biomedical signal analysis, biomedical image analysis, and applications in healthcare, including drug discovery Equips researchers with tools for early breast cancer detection

Artificial Intelligence in Oncology Drug Discovery and Development

John Cassidy,Belle Taylor
Artificial Intelligence in Oncology Drug Discovery and Development Book PDF

Author : John Cassidy,Belle Taylor
Publisher : BoD – Books on Demand
Page : 194 pages
File Size : 42,7 Mb
Release : 2020-09-09
Category : Medical
ISBN : 9781789846898

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Artificial Intelligence in Oncology Drug Discovery and Development by John Cassidy,Belle Taylor Pdf

There exists a profound conflict at the heart of oncology drug development. The efficiency of the drug development process is falling, leading to higher costs per approved drug, at the same time personalised medicine is limiting the target market of each new medicine. Even as the global economic burden of cancer increases, the current paradigm in drug development is unsustainable. In this book, we discuss the development of techniques in machine learning for improving the efficiency of oncology drug development and delivering cost-effective precision treatment. We consider how to structure data for drug repurposing and target identification, how to improve clinical trials and how patients may view artificial intelligence.

Basic Principles of Drug Discovery and Development

Benjamin E. Blass
Basic Principles of Drug Discovery and Development Book PDF

Author : Benjamin E. Blass
Publisher : Unknown
Page : 128 pages
File Size : 52,6 Mb
Release : 2015
Category : Drug development
ISBN : 1785397877

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Basic Principles of Drug Discovery and Development by Benjamin E. Blass Pdf

Clearly explains the complete drug discovery and development process from a multidisciplinary standpoint.

Drug Development

Marco Rossi,Santina Bertone
Drug Development Book PDF

Author : Marco Rossi,Santina Bertone
Publisher : Nova Science Publishers
Page : 0 pages
File Size : 47,5 Mb
Release : 2013
Category : Drug development
ISBN : 1624177905

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Drug Development by Marco Rossi,Santina Bertone Pdf

In this book, the authors discuss the principles, methodology and emerging challenges of drug development. Topics include outsourcing and technology transfer in pharmaceutical companies; analytical tools and chemometrics in the drug development process; the use of cytometry for drug development of cell cycling inhibitors; and the antiproliferative effects of phenolic compounds isolated from the Brazilian propolis.

The Science and Business of Drug Discovery

Edward D. Zanders
The Science and Business of Drug Discovery Book PDF

Author : Edward D. Zanders
Publisher : Springer
Page : 425 pages
File Size : 47,8 Mb
Release : 2020-11-30
Category : Medical
ISBN : 3030578135

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The Science and Business of Drug Discovery by Edward D. Zanders Pdf

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