Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-09-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Download or read book Addressing the Barriers to Pediatric Drug Development written by Forum on Drug Discovery Development and Translation and published by . This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent--have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 843 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.
Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Download or read book Emergency Care for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2007-06-08 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: Children represent a special challenge for emergency care providers, because they have unique medical needs in comparison to adults. For decades, policy makers and providers have recognized the special needs of children, but the system has been slow to develop an adequate response to their needs. This is in part due to inadequacies within the broader emergency care system. Emergency Care for Children examines the challenges associated with the provision of emergency services to children and families and evaluates progress since the publication of the Institute of Medicine report Emergency Medical Services for Children (1993), the first comprehensive look at pediatric emergency care in the United States. This new book offers an analysis of: • The role of pediatric emergency services as an integrated component of the overall health system. • System-wide pediatric emergency care planning, preparedness, coordination, and funding. • Pediatric training in professional education. • Research in pediatric emergency care. Emergency Care for Children is one of three books in the Future of Emergency Care series. This book will be of particular interest to emergency health care providers, professional organizations, and policy makers looking to address the pediatric deficiencies within their emergency care systems.
Download or read book Adherence and Self Management in Pediatric Populations written by Avani C. Modi and published by Academic Press. This book was released on 2020-01-06 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adherence and Self-Management in Pediatric Populations addresses the contemporary theories, evidence-based assessments, and intervention approaches for common pediatric chronic illnesses. An introductory chapter summarizes the state of the field and provides a general foundation in adherence and self-management. Subsequent chapters focus on specific diseases, ensuring that the scope of knowledge contained therein is current and thorough, especially as the assessments and interventions can be specific to each disease. Case examples are included within each chapter to illustrate the application of these approaches. The book ends with an emerging areas chapter to illuminate the future of adherence science and clinical work. This book will be extremely helpful to professionals beginning to treat youth with suboptimal adherence or for those who conduct adherence research. Experts in the field will benefit from the synthesized literature to aid in clinical decision-making and advancing adherence science. Organized by disease for quick reference Provides case examples to illustrate concepts Incorporates technology-focused measurement and intervention approaches (mobile and electronic health) throughout
Download or read book Pediatric Formulations written by Daniel Bar-Shalom and published by Springer Science & Business Media. This book was released on 2014-01-30 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.
Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Considering the Patient in Pediatric Drug Development written by Klaus Rose and published by Academic Press. This book was released on 2020-11-19 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information
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 The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Fostering Healthy Mental Emotional and Behavioral Development in Children and Youth written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-18 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthy mental, emotional, and behavioral (MEB) development is a critical foundation for a productive adulthood. Much is known about strategies to support families and communities in strengthening the MEB development of children and youth, by promoting healthy development and also by preventing and mitigating disorder, so that young people reach adulthood ready to thrive and contribute to society. Over the last decade, a growing body of research has significantly strengthened understanding of healthy MEB development and the factors that influence it, as well as how it can be fostered. Yet, the United States has not taken full advantage of this growing knowledge base. Ten years later, the nation still is not effectively mitigating risks for poor MEB health outcomes; these risks remain prevalent, and available data show no significant reductions in their prevalence. Fostering Healthy Mental, Emotional, and Behavioral Development in Children and Youth: A National Agenda examines the gap between current research and achievable national goals for the next ten years. This report identifies the complexities of childhood influences and highlights the need for a tailored approach when implementing new policies and practices. This report provides a framework for a cohesive, multidisciplinary national approach to improving MEB health.
Download or read book Drug Research and Development for Adults Across the Older Age Span written by National Academies of Sciences Engineering and Medicine and published by . This book was released on 2021-10-22 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population. On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.
Download or read book Chapter 35 The Importance of Geographic Differences in Pediatric Clinical Trials written by Andrew E. Mulberg and published by Wiley-Blackwell. This book was released on 2009-08-13 with total page 683 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first comprehensive treatmentof this vital topicFor decades, the specific needs of infants, children, and adolescents have been largely ignored in the drug development process, and healthcare providers have most often had to make do with pediatric dosing of drugs that were developed and intended for adults. Now, an awareness of the differences between the pediatric patient and the adult patient have begun to be realized and addressed by the pharmaceutical and wider healthcare industries, as well as the governmental and regulatory bodies that sanction the development and testing of drugs for children.This is the first book to provide a comprehensive treatment of pediatric drug development. Written by a team of experts, it provides industry, academia, and governmental agencies with an understanding of how to properly develop drugs for children without compromising business objectives. The authors address the scientific differences between the pediatric and adult subject in the development of pharmaceutical products. They discuss and consider: ethics--from product concept to production; specific medical needs of children; business rationale for the proper development of drugs for children; and the technical feasibility of studies and processes that are necessary for a proper pediatric drug development program.The book clearly explains the challenges and opportunities facing the entire healthcare community as it strives to improve the health of children worldwide. It demonstrates how these approaches will benefit all stakeholders and, ultimately, provide better and safer drugs for the pediatric population at large.This timely new work is essential reading for academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in pediatric drug development. It also serves as an important textbook for students in pharmacy, science, and medicine courses.
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Download or read book Pediatric Non Clinical Drug Testing written by Alan M. Hoberman and published by John Wiley & Sons. This book was released on 2011-12-28 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.
