Download or read book Improving Medicines for Children in Canada written by The Expert Panel on Therapeutic Products for Infants, Children, and Youth and published by Council of CanadianAcademies. This book was released on 2014-09 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Recognizing the importance of developing safe and effective medicines specifically for children, the Minister of Health, on behalf of Health Canada, asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment of the state of research and regulations leading to the approval of therapeutic products for children, in Canada and abroad. Specifically, this assessment examines the following questions: What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labelled as therapies for infants, children, and youth? How does human development from infancy to youth alter clinical pharmacology and therefore inform pediatric drug investigations? What are best practices to ethically conduct scientifically sound but adaptive drug studies to confirm the safety and effectiveness of drugs for infants, children, and youth? When the participation of infants, children, and youth in drug studies is not feasible, what are the best practices to confirm drug safety and effectiveness in these populations? What are Canada's strengths to contribute to global pharmacovigilance efforts for drugs that may benefit infants, children, and youth?"--Executive summary.
Download or read book Improving Medicines for Children in Canada written by Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth and published by . This book was released on 2014 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: "Recognizing the importance of developing safe and effective medicines specifically for children, the Minister of Health, on behalf of Health Canada, asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment of the state of research and regulations leading to the approval of therapeutic products for children, in Canada and abroad. Specifically, this assessment examines the following questions: What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labelled as therapies for infants, children, and youth? How does human development from infancy to youth alter clinical pharmacology and therefore inform pediatric drug investigations? What are best practices to ethically conduct scientifically sound but adaptive drug studies to confirm the safety and effectiveness of drugs for infants, children, and youth? When the participation of infants, children, and youth in drug studies is not feasible, what are the best practices to confirm drug safety and effectiveness in these populations? What are Canada's strengths to contribute to global pharmacovigilance efforts for drugs that may benefit infants, children, and youth?"--Executive summary.
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 Why We Need More Canadian Health Policy in the Media written by Noralou Roos and published by EvidenceNetwork.ca. This book was released on 2016-06-21 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: Why We Need More Canadian Health Policy in the Media is a compilation of health policy commentaries published by EvidenceNetwork.ca experts in major newspapers in 2015. These articles highlight the most recent evidence on a wide range of health policy topics, including our aging population, healthcare costs and spending, mental health, pharmaceutical policy, the social determinants of health and distinctions between the Canadian and American healthcare system among other topics. This is the fourth volume in the annual series of eBooks produced by EvidenceNetwork.ca, the first being Canadian Health Policy in the News (2013), followed by Making Evidence Matter in Canadian Health Policy (2014) and Navigating the Evidence: Communicating Canadian Health Policy in the Media (2015). We acknowledge the Canadian Institutes for Health Research, Research Manitoba, the Manitoba Centre for Health Policy, the George and Fay Yee Centre for Healthcare Innovation, CIHR’s Institute of Health Services and Policy Research, and their Institute of Population and Public Health, The Canadian Frailty Network, and the University of Manitoba’s Department of Community Health Sciences and Max Rady College of Medicine whose funding supports EvidenceNetwork.ca.
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 Optimizing Treatment for Children in the Developing World written by Stuart MacLeod and published by Springer. This book was released on 2015-05-12 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to communicate current best practice in pediatric clinical pharmacology and clinical pharmacy with special consideration of the prevailing circumstances and most pressing needs in developing countries. It also addresses measures that may be taken in countries with emerging economies through organizational and political adjustments to reduce unacceptable levels of morbidity and mortality among children and pregnant women with treatable diseases.
Download or read book Canadian Immunization Guide written by Canada. Comité consultatif national de l'immunisation and published by . This book was released on 2006 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: The seventh edition of the Canadian Immunization Guide was developed by the National Advisory Committee on Immunization (NACI), with the support ofthe Immunization and Respiratory Infections Division, Public Health Agency of Canada, to provide updated information and recommendations on the use of vaccines in Canada. The Public Health Agency of Canada conducted a survey in 2004, which confi rmed that the Canadian Immunization Guide is a very useful and reliable resource of information on immunization.
Download or read book Building on Canada s Strengths in Regenerative Medicine written by Workshop Steering Committee and published by Council of Canadian Academies. This book was released on 2017 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Many disease treatments manage the symptoms of a condition, but fail to treat its underlying causes. The appeal of regenerative medicine lies in its curative approach. It replaces or regenerates human cells, tissues, or organs to restore or establish normal function using stem cells. A well-established example of regenerative medicine is the use of bone marrow transplants for leukemia. Regenerative medicine has the potential to transform healthcare by treating previously incurable chronic diseases and conditions, including diabetes, heart disease, osteoporosis, and spinal cord injuries. In doing so it could also improve the quality of peoples' lives and generate significant economic benefits. Regenerative medicine is a multidisciplinary field, involving a number of stakeholders throughout the development process; from the scientists who make applied research discoveries which enable the possibility of treatment, through regulatory hurdles and industry investment, to end-point clinicians offering these treatments to patients. The CCA's workshop will bring together experts from a variety of disciplines and sectors to offer insight into the state of regenerative medicine in Canada, and identify opportunities and challenges to ensure future Canadian excellence."--
Download or read book Patient Assessment in Clinical Pharmacy written by Sherif Hanafy Mahmoud and published by Springer. This book was released on 2019-03-28 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive, first-of-its kind title is an indispensable resource for pharmacists looking to learn or improve crucial patient assessment skills relevant to all pharmacy practice settings. Pharmacists’ role as health care practitioners is evolving as they are taking a more active part in primary patient care -- helping patients manage their medications and diseases, providing patient education, and, in some jurisdictions, prescribing and adapting medications. To perform their day-to-day duties, pharmacists are best-served using a framework called the patient care process. This framework involves three steps: patient assessment; care plan development and implementation; and monitoring and follow up. Organized in four parts, this practical book begins with introductory chapters regarding the basics of patient assessment and the patient care process. Part II includes a detailed assessment of common symptoms encountered by pharmacists. Part III discusses assessment of patients with various chronic illnesses. Part IV addresses select specialized topics and assessment considerations. An invaluable contribution to the literature, Patient Assessment in Clinical Pharmacy: A Comprehensive Guide will be of great benefit to pharmacists, regardless of their practice setting, and to pharmacy students as well.
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2016 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality, safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines, from their development to their distribution to patients. In the area of quality control, the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia, and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM), the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs, general texts and ICRS. It noted the report on Phase 6 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further acknowledged the progress of good pharmacopoeial practices (GPhP), and adopted the document on GPhP which was prepared by the consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP), distribution and trade of pharmaceuticals and regulatory practice. It adopted 10 guidelines as listed below as well as 22 new specifications and general texts for inclusion in The International Pharmacopoeia. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.
Download or read book Handbook of Autism and Pervasive Developmental Disorder written by Johnny L. Matson and published by Springer Nature. This book was released on 2022-08-11 with total page 1579 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides a substantive foundation of autism theory and research, including a comprehensive overview, conceptualization, and history of autism spectrum disorder (ASD) and pervasive developmental disorder (PDD). This robust reference work integrates the broad scholarly base of literature coupled with a trenchant analysis of the state of the field in nosology, etiology, assessment, and treatment. Its expert contributors examine findings and controversies (e.g., the actual prevalence of autism) as well as longstanding topics of interest as well as emerging issues from around the globe. In addition, the handbook describes multiple assessments, diagnoses, interventions and treatments for autism and PDD. It addresses such key topics as assessment of core symptoms and comorbidities, risk factors, epidemiology, diagnostic systems, neuroscience as well as issues regarding family adaptation. In addition, the handbook explores the rapidly evolving and expanding topics of medications, diets, fringe and harmful treatments, applied behavior analysis, and early intensive behavioral interventions. Key areas of coverage include: Survey of diagnostic criteria and assessment strategies for autism and pervasive developmental disorder. Genetic, behavioral, biopsychosocial, and cognitive models of autism assessment and treatment. Psychiatric disorders in individuals with ASD. Theory of mind and facial recognition in persons with autism. Diagnostic instruments for assessing core features and challenging behaviors in autism and PDD. Evidence-based psychosocial, pharmacological, and integrative treatments for autism and other developmental disabilities. Interventions specifically for adults with ASD. Training issues for professionals, parents, and other caregivers of individuals with autism and developmental disabilities. Review of findings of successful and promising therapies coupled with guidance on how to distinguish between dubious and effective treatments for autism and PDD. The handbook is an indispensable resource for researchers, professors, graduate students as well as clinicians, therapists, and other practitioners in clinical child and school psychology, child and adolescent psychiatry, social work, special education, behavioral rehabilitation, pediatric medicine, developmental psychology, and all allied disciplines.
Download or read book A Roadmap to Reducing Child Poverty written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-09-16 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: The strengths and abilities children develop from infancy through adolescence are crucial for their physical, emotional, and cognitive growth, which in turn help them to achieve success in school and to become responsible, economically self-sufficient, and healthy adults. Capable, responsible, and healthy adults are clearly the foundation of a well-functioning and prosperous society, yet America's future is not as secure as it could be because millions of American children live in families with incomes below the poverty line. A wealth of evidence suggests that a lack of adequate economic resources for families with children compromises these children's ability to grow and achieve adult success, hurting them and the broader society. A Roadmap to Reducing Child Poverty reviews the research on linkages between child poverty and child well-being, and analyzes the poverty-reducing effects of major assistance programs directed at children and families. This report also provides policy and program recommendations for reducing the number of children living in poverty in the United States by half within 10 years.
Download or read book Textbook of Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2021-10-18 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use. Strom’s Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading. Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in “the real world,” who will respond to the challenges that they encounter.
Download or read book Disease Control Priorities Third Edition Volume 2 written by Robert Black and published by World Bank Publications. This book was released on 2016-04-11 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The evaluation of reproductive, maternal, newborn, and child health (RMNCH) by the Disease Control Priorities, Third Edition (DCP3) focuses on maternal conditions, childhood illness, and malnutrition. Specifically, the chapters address acute illness and undernutrition in children, principally under age 5. It also covers maternal mortality, morbidity, stillbirth, and influences to pregnancy and pre-pregnancy. Volume 3 focuses on developments since the publication of DCP2 and will also include the transition to older childhood, in particular, the overlap and commonality with the child development volume. The DCP3 evaluation of these conditions produced three key findings: 1. There is significant difficulty in measuring the burden of key conditions such as unintended pregnancy, unsafe abortion, nonsexually transmitted infections, infertility, and violence against women. 2. Investments in the continuum of care can have significant returns for improved and equitable access, health, poverty, and health systems. 3. There is a large difference in how RMNCH conditions affect different income groups; investments in RMNCH can lessen the disparity in terms of both health and financial risk.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book Pediatric Cancer Therapeutics Development written by Jorge DiMartino and published by Springer Nature. This book was released on 2022-11-18 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive overview of the scientific, medical, regulatory, and economic considerations associated with the discovery, development, and delivery of novel therapeutics for children with cancer. Co-authored by a diverse team from academic, government, and industry backgrounds, the book describes the steps in the process from the identification of a promising therapeutic target to the evaluation of drug candidates in the various phases of clinical testing and regulatory review. Throughout, special emphasis is placed on the unique biology of pediatric malignancies and the medical and social needs of children and their families. In providing a firm grounding in the drug development process, the book will be of value to all with an interest in how medicines currently used to treat pediatric cancer were made available. This includes trainees as well as established practitioners and others participating in translational and clinical research in the academic setting.
