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Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Author : Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth Publisher : Council of CanadianAcademies Page : 266 pages File Size : 49,6 Mb Release : 2014-09 Category : Drugs ISBN : 9781926558851
Improving Medicines for Children in Canada by Council of Canadian Academies,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth Pdf
Improving Medicines for Children in Canada by Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth Pdf
"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.
Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Publisher : National Academies Press Page : 432 pages File Size : 42,6 Mb Release : 2012-10-13 Category : Medical ISBN : 9780309225496
Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf
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.
Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis Publisher : John Wiley & Sons Page : 782 pages File Size : 43,9 Mb Release : 2013-05-20 Category : Medical ISBN : 9781118312056
Pediatric Drug Development by Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis Pdf
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.
Why We Need More Canadian Health Policy in the Media by Noralou Roos,Kathleen O'Grady,Eileen Boriskewich,Mélanie Meloche-Holubowski,Carolyn Shimmin,Kristy Wittmeier,Nanci Armstrong Pdf
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.
Petar Mamula,Jonathan E. Markowitz,Robert N. Baldassano
Author : Petar Mamula,Jonathan E. Markowitz,Robert N. Baldassano Publisher : Springer Science & Business Media Page : 573 pages File Size : 54,7 Mb Release : 2012-12-14 Category : Medical ISBN : 9781461450610
Pediatric Inflammatory Bowel Disease by Petar Mamula,Jonathan E. Markowitz,Robert N. Baldassano Pdf
Pediatric Inflammatory Bowel Disease, Second Edition provides an essential reference with an emphasis on the unique pediatric issues of IBD. Chapters focus on complications of IBD specific to children and adolescents. Treatment recommendations are based on the latest clinical research available. The textbook also presents sections dedicated to the aspects of participation in clinical research unique to children and adolescents and the complicated yet vital process of successfully transitioning a patient from a pediatric to adult specialist. Controversies in pediatric IBD care such as the off-label use of medications are also covered. The format incorporates multiple tables, graphs, and figures to improve readability and make for an efficient reference for clinicians to use. Thoroughly revised and updated from the first edition, the volumes includes new therapies that are currently being used or tested for treatment of IBD, important areas regarding incidence and prevalence, immunization and response to vaccine administration as well as advancements in our understanding of growth and development with particular to the use of growth hormone therapy. Other new areas covered include important topics of complementary and alternative medicine use in IBD, immunization, and liver disease in IBD. Pediatric Inflammatory Bowel Disease, Second Edition is a valuable resource for pediatric gastroenterologists as well as adult gastroenterologists.
Infant and Child Mortality in the Past by Alain Bideau,Bertrand Desjardins,Héctor Pérez Brignoli Pdf
This volume examines the trends of early-age mortality across time and space and the methodological and theoretical problems inherent in such studies. The approach is interdisciplinary, with contributions from demography, biology, medicine, and economic and social history. The geographical range encompasses Europe, North America, Japan, and India.
Optimizing Treatment for Children in the Developing World by Stuart MacLeod,Suzanne Hill,Gideon Koren,Anders Rane Pdf
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.
From the 1920s when he watched his father, a general practitioner who made housecalls and wrote his prescriptions in Latin, to his days in medical school and beyond, Lewis Thomas saw medicine evolve from an art into a sophisticated science. The Youngest Science is Dr. Thomas's account of his life in the medical profession and an inquiry into what medicine is all about--the youngest science, but one rich in possibility and promise. He chronicles his training in Boston and New York, his war career in the South Pacific, his most impassioned research projects, his work as an administrator in hospitals and medical schools, and even his experiences as a patient. Along the way, Thomas explores the complex relationships between research and practice, between words and meanings, between human error and human accomplishment, More than a magnificent autobiography, The Youngest Science is also a celebration and a warning--about the nature of medicine and about the future life of our planet.
Building on Canada's Strengths in Regenerative Medicine by Workshop Steering Committee Pdf
"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."--
Canadian Immunization Guide by Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization Pdf
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.
Patient Assessment in Clinical Pharmacy by Sherif Hanafy Mahmoud Pdf
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.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies Publisher : National Academies Press Page : 235 pages File Size : 48,8 Mb Release : 2018-03-01 Category : Medical ISBN : 9780309468084
Making Medicines Affordable by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies Pdf
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author : World Health Organization Publisher : World Health Organization Page : 374 pages File Size : 48,9 Mb Release : 2016 Category : Medical ISBN : 9789241209960
WHO Expert Committee on Specifications for Pharmaceutical Preparations by World Health Organization Pdf
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.
