Safe and Effective Medicines for Children PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Safe and Effective Medicines for Children PDF full book. Access full book title Safe and Effective Medicines for Children by Institute of Medicine. Download full books in PDF and EPUB format.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
Get Book Here
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: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
Get Book Here
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: Edward A. Bell
Publisher: Johns Hopkins University Press
ISBN: 1421423758
Category : Health & Fitness
Languages : en
Pages : 156
Get Book Here
Book Description
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 informationFull 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: Edward A. Bell
Publisher: JHU Press
ISBN: 142140673X
Category : Health & Fitness
Languages : en
Pages : 180
Get Book Here
Book Description
In A Parent's Guide to Children's Medicines, an experienced pediatric pharmacist answers questions about how to give safe and effective medications to children. Whether medicine is used to treat asthma or ear infections, medicine is often necessary and can be life saving—yet many parents worry about side effects and possible long-term consequences. This book tells parents how drugs for children are prescribed and used, and how to give these medications to children for the best results. Inside: • information to help parents weigh the benefits and risks of medicines • descriptions of medicine for treating fever, infection, and common illnesses • practical tips on measuring, flavoring, and administering liquid medicines • directions for giving medicine in the mouth, the nose, the ear, and the eye • advice for keeping children safe around medications • facts about vaccinations: how do they work, and are they safe? • answers to parents’ frequently asked questions
Author: KR Suneja
Publisher: Jaypee Brothers Medical Publishers
ISBN: 9388958594
Category : Medical
Languages : en
Pages : 545
Get Book Here
Book Description
Author: Daniel Bar-Shalom
Publisher: Springer Science & Business Media
ISBN: 1489980113
Category : Medical
Languages : en
Pages : 429
Get Book Here
Book Description
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.
Author: Great Britain: Parliament: House of Lords: European Union Committee
Publisher: The Stationery Office
ISBN: 9780104008096
Category : Medical
Languages : en
Pages : 132
Get Book Here
Book Description
Over 50 per cent of all medicines given to children (and about 90 per cent of those given to the newly-born) have never been tested or authorised for use on them. The Committee's report examines the European Commission's proposal to introduce a Regulation (the Clinical Trials Directive) on medicinal products for paediatric use which aims to stimulate the development of medicines for children and lay down rules for testing and approval. Issues discussed include: the need for better regulation of paediatric medicines; the ethical considerations involved in clinical trials on children, including the issue of consent; mechanisms for implementing the Regulation; access to the database of information on clinical trials; the rewards and incentives proposed to stimulate the research and development of medicines; and the legal basis for the regulation under the EC Treaty. The Committee's report recognises the urgent need for effective action at the European level to authorise medicines for paediatric use and gives broad support to the proposed Directive. However, a number of key issues are highlighted, including: the need for improved labelling of medicines; that the guidelines underpinning the Directive should take account of ethical considerations involved to ensure the rights and capacity of children to give informed consent to trials; and concerns are raised about the adequacy of proposed incentive mechanisms.
Author: Ian Costello
Publisher: Pharmaceutical Press
ISBN: 9780853696865
Category : Medical
Languages : en
Pages : 148
Get Book Here
Book Description
This book provides a comprehensive overview of all of the issues pharmacists serving pediatric patients must consider. Chapters relating to pharmacogenomics, medication error prevention, compounding, and government regulations are extremely informative.
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118210433
Category : Medical
Languages : en
Pages : 843
Get Book Here
Book Description
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241563435
Category : Medical
Languages : en
Pages : 65
Get Book Here
Book Description
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: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782
Get Book Here
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.
