Safe And Effective Medicines For Children

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 : 52,9 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

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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.

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 : 40,7 Mb
Release : 2014-09
Category : Drugs
ISBN : 9781926558851

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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

Author : Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher : Unknown
Page : 128 pages
File Size : 50,5 Mb
Release : 2014
Category : Drugs
ISBN : 1926558863

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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.

Author : Mike Sharland
Publisher : Unknown
Page : 0 pages
File Size : 52,5 Mb
Release : 2019-07-17
Category : Chemotherapy
ISBN : 0857111353

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Prescribing Medicines for Children by Mike Sharland Pdf

Prescribing for children is a particularly challenging discipline due to specific issues of drug absorption, metabolism, distribution and excretion. The aim of this book is to improve understanding in all aspects of paediatric prescribing, from the development of suitable drugs through to their practical administration. With its origins in the EU-funded Global Research in Paediatrics (GRiP) project this is the first truly international textbook to provide guidance on the principles behind optimal neonatal and paediatric prescribing. Harnessing the international expertise of paediatricians and pharmacists in the field, Prescribing Medicines for Children compliments the British National Formulary for Children (BNFC), facilitating translation of essential pharmacological principles into good prescribing practice. It incorporates specific information on how to promote safe and effective prescribing in paediatrics, including how to avoid medication errors and adverse drug reactions in children. Highlights include the differences in prescribing habits between countries and the shared principles that underpin rational prescribing in paediatrics and neonatology. The book is divided into two sections: Section A provides concise educational material relating to paediatric pharmacology and optimising how medicines are developed and prescribed for children. Section B considers key clinical prescribing areas and can be used as a quick reference guide. Each chapter is focused on the key issues in prescribing for a respective clinical specialty or context. Prescribing Medicines for Children is essential reading for all those who are involved in prescribing medicines to neonates and children. This includes undergraduate and postgraduate pharmacists, nurses, paediatricians and primary care physicians, academic scientists, and those working in the pharmaceutical industry and drug regulation.

Author : May Loo
Publisher : Elsevier Health Sciences
Page : 533 pages
File Size : 40,5 Mb
Release : 2009
Category : Health & Fitness
ISBN : 9781416022992

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Integrative Medicine for Children by May Loo Pdf

"Many parents today are turning to or seeking information about Complementary and Alternative Medicine (CAM) for their children. Whether you initiate alternative therapies or simply need to respond when asked for information or advice, it's crucial to have the most recent, evidence-based information about alternative therapies and know how to safely and effectively integrate them with conventional treatment. This innovative and reliable reference is the ideal resource to have at hand." "This book includes a wide range of complementary and alternative therapies, focusing on those most often used with children: mind/body approaches, manual therapies, lifestyle approaches, alternative systems, energy medicine, and biological agents. Within these main categories, therapies such as acupuncture, chiropractic, massage, homeopathy, herbs, and magnets are covered." "Fifty-five common pediatric conditions are comprehensively discussed, with diagnostic and evidence-based treatment information, followed by authoritative information on the major CAM therapies available for treatment of the condition. Whenever possible, an integrative approach that combines conventional and alternative approaches is presented."--BOOK JACKET.

Author : World Health Organization
Publisher : World Health Organization
Page : 65 pages
File Size : 50,8 Mb
Release : 2007
Category : Medical
ISBN : 9789241563437

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Promoting Safety of Medicines for Children by World Health Organization Pdf

Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.

Author : WHO Expert Committee on the Selection and Use of Essential Medicines
Publisher : WHO
Page : 144 pages
File Size : 55,9 Mb
Release : 2004
Category : Medical
ISBN : IND:30000093001240

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The Selection and Use of Essential Medicines by WHO Expert Committee on the Selection and Use of Essential Medicines Pdf

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.

Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publisher : John Wiley & Sons
Page : 624 pages
File Size : 44,7 Mb
Release : 2013-05-20
Category : Medical
ISBN : 9781118312056

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Pediatric Drug Development by Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis Pdf

Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.

Author : Janet Zand,Robert Rountree,Rachel Walton
Publisher : Penguin
Page : 582 pages
File Size : 45,7 Mb
Release : 2003-01-06
Category : Health & Fitness
ISBN : 1583331395

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Smart Medicine for a Healthier Child by Janet Zand,Robert Rountree,Rachel Walton Pdf

Revised, updated, and expanded to reflect the latest thinking and information on children's health issues, Smart Medicine for a Healthier Child enables parents to combine the best of conventional and alternative approaches. Part One explains the full spectrum of techniques that can be employed to effectively treat childhood health problems, providing an overview of the history, fundamentals, and uses of conventional medicine, herbal medicine, homeopathy, acupressure, diet, and nutritional supplementation. Part Two contains a comprehensive A-to-Z guide to the various health problems of childhood, from acne to chickenpox to thumb-sucking. Finally, Part Three offers guidance on using the therapies and procedures suggested in Part Two, from locating acupressure points to preparing herbal remedies. Written by a naturopathic physician, a medical doctor, and a pediatric nurse, this unique book gives parents easy access to current information and advice regarding their children's health and acts as a bridge between time-honored healing systems and mainstream medicine. Illustrated with line art.

Author : N. Mohamed Shah
Publisher : Unknown
Page : 128 pages
File Size : 43,7 Mb
Release : 2012
Category : Electronic
ISBN : OCLC:784569935

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Safe and Effective Use of Medicines in Children by N. Mohamed Shah Pdf

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 49,8 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160

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Ethical and Scientific Issues in Studying the Safety of Approved Drugs by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs Pdf

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Author : Edward A. Bell
Publisher : JHU Press
Page : 156 pages
File Size : 47,7 Mb
Release : 2017-12
Category : Family & Relationships
ISBN : 9781421423746

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Children's Medicines by Edward A. Bell Pdf

An indispensable guide to children’s medications that belongs on the bookshelf of every parent, grandparent, and teacher. Most parents have worried about the side effects and possible long-term consequences of administering a particular medication to their child. The medication may be available over-the-counter, like cough syrup, or it may be prescribed by a doctor, like an antibiotic. Parents want to know: Is the medication safe? Is it effective? Will it help my child? A pediatric pharmacist for nearly thirty years, Edward A. Bell has spent his career listening carefully to parents' concerns. In Children's Medicines, Bell draws on the latest scientific information, coupled with his experience in hospital and clinic settings, as a university professor, and as a parent, to answer questions about whether, when, and what medications to give to infants, children, and teenagers. Bell touches on practical issues of medication administration and explores areas of particular concern for parents. Inside the book, readers will find • information to help parents weigh the benefits and risks of medicines • an explanation of why some adult medications are not safe for children • descriptions of medicine for treating fever and common illnesses • practical tips on measuring, flavoring, and administering medicines • directions for giving medicine in the mouth, the nose, the ear, and the eye • advice for keeping children of any age safe around medications • facts about vaccinations: how they work, which ones are recommended, and their safety • a guide to the FDA's approval process for use of medicines by children • information about drug pricing, expiration dates, and storing medicine at home • a chapter on ADHD and the treatment of adolescent depression that takes into account the long-term side effects of antidepressants • details about the use of herbal and complementary therapies, including probiotics and vitamins • a discussion of over-the-counter cough/cold products • information on which websites to use for accurate medical and drug information Full of information helpful to parents, grandparents, and others who provide care for children, Children's Medicines is a reliable and insightful guide to how drugs for children of all ages are prescribed and used.

Author : Centers for Disease Control and Prevention CDC
Publisher : Oxford University Press
Page : 672 pages
File Size : 55,6 Mb
Release : 2017-04-17
Category : Medical
ISBN : 9780190628635

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CDC Yellow Book 2018: Health Information for International Travel by Centers for Disease Control and Prevention CDC Pdf

THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.

Author : Institute of Medicine,Division of Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices,Jonathan R. Davis,Sarah Pitluck,Peter Bouxsein,Ronald W. Estabrook
Publisher : National Academies Press
Page : 135 pages
File Size : 48,5 Mb
Release : 2000-04-07
Category : Medical
ISBN : 9780309183642

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Rational Therapeutics for Infants and Children by Institute of Medicine,Division of Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices,Jonathan R. Davis,Sarah Pitluck,Peter Bouxsein,Ronald W. Estabrook Pdf

The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Author : Mariam Hantash Abdel Jalil
Publisher : Unknown
Page : 0 pages
File Size : 43,5 Mb
Release : 2014
Category : Electronic
ISBN : OCLC:1179473765

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Safe and Effective Use of Medicines in Children by Mariam Hantash Abdel Jalil Pdf