Guide to Paediatric Clinical Research PDF Download

Author: Klaus Rose
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805582013
Category : Medical
Languages : en
Pages : 164

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Book Description
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.

Author: K. Rose
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805593635
Category : Medical
Languages : en
Pages : 240

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Book Description
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445

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Book Description
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

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: Osama Naga
Publisher: Springer
ISBN: 3319101153
Category : Medical
Languages : en
Pages : 611

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Book Description
Covers the most frequently asked and tested points on the pediatric board exam. Each chapter offers a quick review of specific diseases and conditions clinicians need to know during the patient encounter. Easy-to-use and comprehensive, clinicians will find this guide to be the ideal final resource needed before taking the pediatric board exam.

Author: Tom Lissauer
Publisher: Elsevier Health Sciences
ISBN: 0702066125
Category : Medical
Languages : en
Pages : 823

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Book Description
"This book is innovative and original in assisting the reader to apply the principles of science to paediatric practice" -Professor Neena Modi, Former President, Royal College of Paediatrics and Child Health. The Science of Paediatrics, MRCPCH Mastercourse, provides essential background preparation for the MRCPCH Theory and Science examination. It contains an up-to-date review of the application of science to everyday paediatric clinical practice, whether it is interpreting clinical signs or investigations, prescribing drugs or identifying best management. Although this understanding is essential in order to make informed clinical decisions, it is diffi cult to obtain as it is not usually covered in clinical textbooks. - MRCPCH exam-format questions embedded in each chapter to test understanding - Emphasis on embryology to explain many congenital abnormalities - An overview of the relevant anatomy and physiology - Focus on the application and interpretation of investigations - Examples of recent advances in science and clinical research that have benefitted the children's care - All clinical specialties covered by paediatric specialists - Chapters covering evidence-based paediatrics, statistics, ethics and quality improvement

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241548371
Category : Business & Economics
Languages : en
Pages : 442

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Book Description
The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.

Author: Hesham Abdeldayem
Publisher: BoD – Books on Demand
ISBN: 1789232384
Category : Medical
Languages : en
Pages : 91

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Book Description
This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.

Author: Anwar Qais Saadoon
Publisher: Springer
ISBN: 3319924265
Category : Medical
Languages : en
Pages : 251

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Book Description
This book is a concise learning guide dedicated to the full scope of pediatric history-taking and clinical examination, for use in OSCEs as well as clinical life. It guides the reader simply and methodically through what to ask when taking a history, and how to perform a comprehensive physical examination. The book contains more than 30 “History Stations” covering the most common pediatric cases, as well as 10 “Examination Stations” covering examinations of the different body system. It provides students and resident doctors worldwide with the necessary core information for pediatric history-taking and clinical examination, all in a brief and interesting format. The book adopts a reader-friendly format through a lecture-note style and the use of Key Points, Clinical Tips, Notes, Tables, and Boxes listing the most important features. It is also richly illustrated, demonstrating the correct way to perform clinical examinations. Written “by a resident, for residents and medical students,” this book has been revised, foreworded, and peer-reviewed by fourteen prominent authorities in the field of Pediatrics from various parts of the world (including the United States, United Kingdom, Australia, Italy, Canada, and India), and from different universities (Illinois, Pennsylvania, Washington, Oxford, Edinburgh, Keele, Melbourne, Toronto, Parma, and Florence Universities). These experts recommend this book for medical students, pediatric residents, and pediatric practitioners, as well as pediatricians.

Author: Rebecca Hewitson
Publisher: John Wiley & Sons
ISBN: 1118463528
Category : Medical
Languages : en
Pages : 290

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Book Description
Winner of the Paediatrics category at the BMA Book Awards 2015 About to start a paediatrics rotation? Working with children for the first time? Thinking about a career in paediatrics? The Hands-on Guide to Practical Paediatrics is the ultimate practical guide for medical students encountering paediatrics for the first time, junior doctors thinking about working with children, and new paediatric trainees. It’s full of vital information on practical procedures, prescribing for young patients, and communicating with children and young people, as well as guidance on the paediatric training programme and paediatrics as a career. Full of clinical tips, and covering key information on developmental stages, common paediatric emergencies and ethical dilemmas, and child protection, The Hands-on Guide to Practical Paediatrics is also supported by online resources including practice prescribing scenarios and video content at www.wileyhandsonguides.com/paediatrics Take the stress out of paediatrics with The Hands-on Guide!