Download or read book Imaging in Drug Discovery and Early Clinical Trials written by Markus Rudin and published by Springer Science & Business Media. This book was released on 2006-07-11 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Imaging in CNS Drug Discovery and Development written by David Borsook and published by Springer Science & Business Media. This book was released on 2010-03-10 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development today needs to balance agility, speed, and risk in defining probability of success for molecules, mechanisms, and therapeutic concepts. New techniques such as fMRI promise to be part of a sequence that could transform drug development. Although numerous review articles exist that discuss the use of imaging in drug development, no one source is available that combines the various techniques and includes a discussion of disease mapping. Imaging in CNS Drug Discovery and Development, Implications for Disease and Therapy will serve to distill the most salient developments in the use of imaging in drug development and disease mapping. It will launch evolving concepts that integrate new imaging technologies and paradigms with molecular medicine and molecular profiling ("monics") as well as consider the ethical issues that arise as a result of disease or state diagnosis and the use of imaging in the public eye.

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Early Drug Development written by Mitchell N. Cayen and published by John Wiley & Sons. This book was released on 2011-02-25 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Download or read book Pharmaco Imaging in Drug and Biologics Development written by Brian R. Moyer and published by Springer Science & Business Media. This book was released on 2013-11-08 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The volume aim to be a comprehensive overview of the drug and biologic development process that is often called “the valley of death” (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve advanced development with added certainty of a drug or biologic’s success to senior corporate management and investors. There are numerous textbooks, reference texts and treatises on medical imaging technologies, teaching tools on medical cases and physics books on the science of detector and computer interface systems. Rarely, in each of these are examples of medical imaging protocols and animal models of disease i.e. a text on methodology in drug development is currently unavailable.

Download or read book Handbook for Clinical Trials of Imaging and Image Guided Interventions written by Nancy A. Obuchowski and published by John Wiley & Sons. This book was released on 2016-02-15 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook for Clinical Trials of Imaging and Image-Guided Interventions is the first single-source, multi-disciplinary reference, based on the didactic sessions presented at the annual ‘Clinical Trials Methodology Workshop’ for radiologists, radiation oncologists and imaging scientists (sponsored by the Radiological Society of North America (RSNA)). It focuses on educating radiologists, radiation oncologists and those involved in imaging research with how to design and conduct clinical trials to evaluate imaging technology and imaging biomarkers. The internationally renowned contributors take a broad approach, starting with principles of technology assessment, and then move into specific topics covering the clinical trials of therapy and clinical research in imaging guided interventions including radiotherapy. They discuss the use of imaging as a predictor of therapeutic response, screening trial design, and the practicalities of how to run an efficient clinical trial and good working practices. Later chapters provide a comprehensive array of quantitative methods including: an introduction to statistical considerations in study design, biostatistical analysis methods and their role in clinical imaging research, methods for quantitative imaging biomarker studies, and an introduction to cost effectiveness analysis. Handbook for Clinical Trials of Imaging and Image-Guided Interventions will educate and prepare radiologists at all levels and in all capacities in planning and conducting clinical imaging trials.

Download or read book From Morphological Imaging to Molecular Targeting written by Markus Schwaiger and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: The current progress in molecular medicine allows the identification of a plethora of new and often human-specific drug targets. An early in vivo validation of specific ligands binding to these targets in humans is needed to assess their potential for targeted imaging and radiotherapy. Radiopharmaceuticals are uniquely suitable for such target validation studies. The purpose of the Ernst Schering Research Foundation Workshop 48 was to offer a forum for an open exchange on the state of the art in the early development of such radiopharmaceuticals. Experts from academia, industry and regulatory authorities provided contributions covering the identification of targets, the necessary preclinical studies on the safety of ligands as well as their validation in human clinical trials.

Download or read book Theranostics and Image Guided Drug Delivery written by Maya Thanou and published by Royal Society of Chemistry. This book was released on 2018-01-02 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: Molecular imaging of drugs or drug carriers is a valuable tool that can provide important information on spatiotemporal distribution of drugs, allowing improved drug distribution at target sites. Chemically labelled drugs can be used to both diagnose and treat diseases. This book introduces the topic of image guided drug delivery and covers the latest imaging techniques and developments in theranostics, highlighting the interdisciplinary nature of this field as well as its translational ability. These technologies and techniques hold potential for individualised, safer therapies. The book introduces the chemistry behind labelling drugs or drug carriers for imaging. It then discusses current scientific progress in the discovery and development of theranostic agents as well as the latest advances in triggered drug delivery. Novel imaging techniques that can be combined with therapeutics are presented, as well as results and findings from early clinical trials. This text will provide postgraduates and researchers in various disciplines associated with drug discovery, including chemistry, device engineering, oncology, neurology, cardiology, imaging, and nanoscience, an overview of this important field where several disciplines have been combined to improve treatments. Readers will be introduced to techniques that can be translated to the clinic and be applied widely.

Download or read book Biomarkers in Drug Discovery and Development written by Ramin Rahbari and published by John Wiley & Sons. This book was released on 2020-02-28 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring Includes case studies of biomarkers that have helped and hindered decision making Reviews of the first edition: "If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)

Download or read book Critical Pathways to Success in CNS Drug Development written by Neal R. Cutler and published by John Wiley & Sons. This book was released on 2010-01-22 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering the latest advances in CNS drug development, this bookwill guide all those involved in pre-clinical to early clinicaltrials. The authors describe how recent innovations can acceleratethe development of novel CNS compounds, improve early detection ofefficacy and toxicity signals, and increase the safety oflater-stage clinical trials. The current crisis in the drug development industry iscritically reviewed, as well as the steps needed to correct theproblems, including new government-backed regulations andindustry-based innovations designed to accelerate CNS drugdevelopment in the future. Animal-based models of major CNS disorders are described indetail, and the ability of the latest in vitro and computer-basedmodels to simulate CNS disease states and predict drug efficacy andside-effects are examined. Particular attention is given tothe growing use of biomarkers and how they can be used effectivelyin early human trials as signals of potential drug efficacy, aswell as the increasingly important role of imaging studies to guidedose selection. Cognitive assessments that can be useful indicatorsof effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drugtrials for over 20 years, and based on a wealth of drug developmentand clinical trial experience, Critical Pathways to Success inCNS Drug Developmentis full of practical advice forsuccessfully designing and executing CNS drug trials, avoidingpotential pitfalls, and complying with government regulations

Download or read book Trends on the Role of PET in Drug Development written by Philip H. Elsinga and published by World Scientific. This book was released on 2012 with total page 799 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is very expensive and a fight against time. PET offers possibilities to speed up this process by adding unique in vivo information on pharmacokinetics/dynamics of a drug at an early stage. This information can help decision makers to move the drug in the drug development process or to decide to stop further developments. This unique and complete book highlights the different ways PET can be used and describes the latest trends in the various disciplines within nuclear medicine to further improve methodologies and increase the number of tools to accelerate drug development. Various topics within tracer development, instrumentation, data analysis and many clinical and preclinical topics are described by leading scientists from industry and academia.

Download or read book Drug Discovery and Development written by Raymond G Hill and published by Elsevier Health Sciences. This book was released on 2021-05-16 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Modern CNS Drug Discovery written by Rudy Schreiber and published by Springer Nature. This book was released on 2021-06-17 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook provides a comprehensive overview of the currently used concepts, approaches and technologies in the discovery and development of new treatments for the full spectrum of disorders of the central nervous system. It guides the reader through all essential steps, from finding an innovative idea, to the registration of a new drug. Divided into four sections, the book starts by presenting a broad perspective on current approaches in central nervous system (CNS) drug discovery. The second section addresses the generation of ideas for the identification of targets and novel treatment strategies; covers core functions in early discovery, and provides an example of a novel treatment paradigm: brain stimulation. The third section highlights strategies and technologies in translational CNS drug discovery. In an effort to bridge the gap between discovery and clinical development, it also covers brain imaging, EEG and cognitive testing approaches. The fourth section extensively discusses the clinical phase of drug development, covering the basics of early clinical testing for psychopharmacological drugs. The book’s final chapter addresses the registration for newly developed drugs. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments in drug discovery. Offering in-depth insights into the world of drug development, it represents essential reading for early researchers who want to prepare for a career in drug discovery in academia or industry.

Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Download or read book PET for Drug Development and Evaluation written by D. Comar and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: Can drug development and evaluation be improved by the use of positron emission tomography (PET)? PET is now well established and many PET centres participate in networks that warrant the quality of their research. PET allows one to follow the effect of a drug on a variety of patients' metabolic parameters. In addition, PET may be used to follow the fate in vivo of a compound, allowing visualisation of its binding to specific receptors and a direct study of the mechanism of drug action in normal and pathological situations. The book shows the fields in which PET offers new and unique information for the development of drugs (conception, toxicity, pharmacokinetics and metabolism, clinical research, and relations between clinical and biological effects) and evaluates fields in which PET may shorten the development time of drugs. Audience: Professionals in the pharmaceutical industry in all areas of drug discovery and pharmacology, pre-clinical testing, pharmacokinetics and metabolism, clinical evaluation, registration and regulatory affairs. Government health authority representatives who assess data and documentation on new drug development and radiopharmaceuticals. Academic experts concerned with any of these areas.

Download or read book Novel Designs of Early Phase Trials for Cancer Therapeutics written by Shivaani Kummar and published by Academic Press. This book was released on 2018-05-22 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development