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Author: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher: Council of CanadianAcademies
ISBN: 1926558855
Category : Medical
Languages : en
Pages : 292
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Book Description
"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.
Author: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher: Council of CanadianAcademies
ISBN: 1926558855
Category : Medical
Languages : en
Pages : 292
Get Book
Book Description
"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.
Author: Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher:
ISBN: 9781926558868
Category : Drugs
Languages : en
Pages :
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Book Description
"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.
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
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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: Noralou Roos
Publisher: EvidenceNetwork.ca
ISBN: 0995157324
Category : Medical
Languages : en
Pages : 351
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Book Description
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.
Author: Canada. Comité consultatif national de l'immunisation
Publisher:
ISBN: 9780660193922
Category : Immunization
Languages : en
Pages : 392
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Book Description
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.
Author: Stuart MacLeod
Publisher: Springer
ISBN: 3319157507
Category : Medical
Languages : en
Pages : 332
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Book Description
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.
Author: Alain Bideau
Publisher: Oxford University Press
ISBN: 9780198289951
Category : Family & Relationships
Languages : en
Pages : 362
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Book Description
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.
Author: Workshop Steering Committee
Publisher: Council of Canadian Academies
ISBN: 1926522230
Category : Electronic books
Languages : en
Pages : 60
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Book Description
"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."--
Author: Sherif Hanafy Mahmoud
Publisher: Springer
ISBN: 3030117758
Category : Medical
Languages : en
Pages : 432
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Book Description
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.
