Essentials of Translational Pediatric Drug Development PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Essentials of Translational Pediatric Drug Development PDF full book. Access full book title Essentials of Translational Pediatric Drug Development by Elke Gasthuys. Download full books in PDF and EPUB format.
Author: Elke Gasthuys Publisher: Elsevier ISBN: 0323904297 Category : Medical Languages : en Pages : 732
Book Description
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development
Author: Elke Gasthuys Publisher: Elsevier ISBN: 0323904297 Category : Medical Languages : en Pages : 732
Book Description
Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309225493 Category : Medical Languages : en Pages : 432
Book Description
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author: Robert A. McArthur Publisher: Academic Press ISBN: 0080920381 Category : Medical Languages : en Pages : 413
Book Description
Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer's disease, Parkinson's disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. - Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process - Critical evaluation of animal and translational models improving transition from drug discovery and clinical development - Emphasis on what results mean to the overall drug discovery process - Exploration of issues in clinical trial design and conductance in each therapeutic area
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309158060 Category : Medical Languages : en Pages : 442
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309498511 Category : Medical Languages : en Pages : 103
Book Description
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.
Author: Amir Kalali Publisher: Cambridge University Press ISBN: 1139576526 Category : Medical Languages : en Pages : 219
Book Description
Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.
Author: Daria Mochly-Rosen Publisher: Springer Science & Business Media ISBN: 3319022016 Category : Medical Languages : en Pages : 186
Book Description
"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
Author: Debra Lerner Publisher: Springer Nature ISBN: 3030830284 Category : Medical Languages : en Pages : 254
Book Description
Despite the large U.S. investment in health science, and the vast and growing body of peer-reviewed research findings it has produced, a compelling body of evidence suggests that research too often has been slow, inefficient, and fallen short of desired impacts on health. A key question is how research might be changed to be more innovative, less wasteful, and more responsive to unmet health needs. One emerging response within clinical and translational science is to advance an approach that attempts to close the gap between research scientists and key stakeholders; the individuals and groups responsible for or affected by health-related decisions. Broadly engaged team science promises to support this aim by transforming the gold standard, multi-disciplinary team science, to include key stakeholders in activities across the research spectrum. These new roles and responsibilities range from generating research questions to implementing research projects, to aiding in the translation of discoveries from the laboratory to the community. A transition to broadly engaged team science reflects the idea that inclusivity and a diversity of perspectives are necessary to achieving progress in addressing complex health issues while representing a new benchmark for ethical research practice. This is one of the first collections of papers describing how clinical and translational science researchers are defining and implementing new research practices, and the successes and challenges involved. This book represents a first and critical step towards organizing knowledge of broadly engaged team science and advancing the development of evidence-based practices. Written in an accessible style, this book is intended to highlight the breadth of broadly engaged team science within one community, motivate researchers and stakeholders to build inclusive teams, bring rigor to often informal stakeholder engagement research practices and encourage people to think more broadly about the development of scientific knowledge. It includes examples of multi-disciplinary, broadly engaged team science projects, the perspectives of academic leaders about the changes needed to encourage scientists to conduct broadly engaged team science, and a resource directory.
Author: Donald Y. M. Leung Publisher: Elsevier Health Sciences ISBN: 1437737781 Category : Medical Languages : en Pages : 705
Book Description
Pediatric Allergy supplies the comprehensive guidance you need to diagnose, manage, and treat virtually any type of allergy seen in children. Drs. Leung, Sampson, Geha, and Szefler present the new full-color second edition, with coverage of the diagnosis and management of anaphylaxis, the immune mechanisms underlying allergic disease, the latest diagnostic tests, and more. Treat the full range of pediatric allergic and immunologic diseases through clinically focused coverage relevant to both allergists and pediatricians. Understand the care and treatment of pediatric patients thanks to clinical pearls discussing the best approaches. Easily refer to appendices that list common food allergies and autoantibodies in autoimmune diseases. Apply the newest diagnostic tests available—for asthma, upper respiratory allergy, and more—and know their benefits and contraindications. Treat the allergy at its source rather than the resulting reactions through an understanding of the immune mechanisms underlying allergic diseases. Get coverage of new research that affects methods of patient treatment and discusses potential reasons for increased allergies in some individuals. Better manage potential anaphylaxis cases through analysis of contributing facts and progression of allergic disease. Effectively control asthma and monitor its progression using the new step-by-step approach. Eliminate difficulty in prescribing antibiotics thanks to coverage of drug allergies and cross-reactivity.
Author: Katrin Scheinemann Publisher: Springer ISBN: 149391541X Category : Medical Languages : en Pages : 322
Book Description
“The editors...have done an outstanding job of presenting...complex information in a lucid manner – this book is a must-read for the global community of aspiring students and neuro-oncology practitioners.” Amar Gajjar, MD in the Foreword This is a succinct introduction to pediatric neuro-oncology. It summarizes the key advances in molecular biology that have helped transform this rapidly evolving field and provides up-to-date coverage of major and emerging treatment modalities as well as supportive care. Separate chapters present each kind of pediatric brain cancer and its diagnosis and treatment. As more children survive brain cancer, the importance of quality of life issues and helping survivors to cope with the neuropsychological impact and long-term effects of current therapies has come into sharper focus; these topics are also addressed in the book, as are palliative care and pediatric neuro-oncology in countries with limited resources. The book is aimed at trainees and practitioners who seek an up-to-date text in pediatric neuro-oncology that is both comprehensive and concise.
Author: Elke Gasthuys
Author: Elke Gasthuys
Author: Institute of Medicine
Author: Robert A. McArthur
Author: Institute of Medicine
Author: National Academies of Sciences, Engineering, and Medicine
Author: Amir Kalali
Author: Daria Mochly-Rosen
Author: Debra Lerner
Author: Donald Y. M. Leung
Author: Katrin Scheinemann