Pharmaco Imaging In Drug And Biologics Development
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Pharmaco Imaging in Drug and Biologics Development
Author | : Brian R. Moyer,Narayan P.S. Cheruvu,Tom C.-C. Hu |
Publsiher | : Springer Science & Business Media |
Total Pages | : 401 |
Release | : 2013-11-08 |
Genre | : Medical |
ISBN | : 9781461482475 |
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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.
Imaging in CNS Drug Discovery and Development
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 416 |
Release | : 2011-07-11 |
Genre | : Electronic Book |
ISBN | : 1441901353 |
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Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author | : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders |
Publsiher | : National Academies Press |
Total Pages | : 118 |
Release | : 2014-02-06 |
Genre | : Medical |
ISBN | : 9780309292498 |
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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.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development
Author | : Ali S. Faqi |
Publsiher | : Elsevier |
Total Pages | : 1074 |
Release | : 2024-02-11 |
Genre | : Medical |
ISBN | : 9780323984621 |
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A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Modern Methods of Clinical Investigation
Author | : Institute of Medicine,Committee on Technological Innovation in Medicine |
Publsiher | : National Academies Press |
Total Pages | : 241 |
Release | : 1990-02-01 |
Genre | : Medical |
ISBN | : 9780309042864 |
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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.
A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author | : Ali S. Faqi |
Publsiher | : Academic Press |
Total Pages | : 904 |
Release | : 2012-11-02 |
Genre | : Business & Economics |
ISBN | : 9780123878151 |
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A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --
The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
Author | : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services |
Publsiher | : National Academies Press |
Total Pages | : 103 |
Release | : 2020-01-27 |
Genre | : Medical |
ISBN | : 9780309498517 |
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To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Atkinson s Principles of Clinical Pharmacology
Author | : Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr. |
Publsiher | : Academic Press |
Total Pages | : 764 |
Release | : 2021-10-16 |
Genre | : Medical |
ISBN | : 9780128198841 |
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Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK