Guide To Paediatric Clinical Research

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Guide to Paediatric Clinical Research

Author : Klaus Rose
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805582013
Total Pages : 164 pages
Book Rating : 4.8/5 (55 download)

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Book Synopsis Guide to Paediatric Clinical Research by : Klaus Rose

Download or read book Guide to Paediatric Clinical Research written by Klaus Rose and published by Karger Medical and Scientific Publishers. This book was released on 2007 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethical Conduct of Clinical Research Involving Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Guide to Paediatric Drug Development and Clinical Research

Author : Klaus Rose
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805593627
Total Pages : 240 pages
Book Rating : 4.8/5 (55 download)

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Book Synopsis Guide to Paediatric Drug Development and Clinical Research by : Klaus Rose

Download or read book Guide to Paediatric Drug Development and Clinical Research written by Klaus Rose and published by Karger Medical and Scientific Publishers. This book was released on 2010-01-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Safe and Effective Medicines for Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Management of Clinical Trials

Author : Hesham Abdeldayem
Publisher : BoD – Books on Demand
ISBN 13 : 1789232384
Total Pages : 91 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis The Management of Clinical Trials by : Hesham Abdeldayem

Download or read book The Management of Clinical Trials written by Hesham Abdeldayem and published by BoD – Books on Demand. This book was released on 2018-06-06 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pediatric Board Study Guide

Author : Osama Naga
Publisher : Springer
ISBN 13 : 3319101153
Total Pages : 611 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Pediatric Board Study Guide by : Osama Naga

Download or read book Pediatric Board Study Guide written by Osama Naga and published by Springer. This book was released on 2015-03-27 with total page 611 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Science of Paediatrics: MRCPCH Mastercourse

Author : Tom Lissauer
Publisher : Elsevier Health Sciences
ISBN 13 : 0702066125
Total Pages : 823 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis The Science of Paediatrics: MRCPCH Mastercourse by : Tom Lissauer

Download or read book The Science of Paediatrics: MRCPCH Mastercourse written by Tom Lissauer and published by Elsevier Health Sciences. This book was released on 2016-03-21 with total page 823 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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

Pocket Book of Hospital Care for Children

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241548371
Total Pages : 442 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Pocket Book of Hospital Care for Children by : World Health Organization

Download or read book Pocket Book of Hospital Care for Children written by World Health Organization and published by World Health Organization. This book was released on 2013 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pediatric Formulations

Author : Daniel Bar-Shalom
Publisher : Springer Science & Business Media
ISBN 13 : 1489980113
Total Pages : 429 pages
Book Rating : 4.4/5 (899 download)

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Book Synopsis Pediatric Formulations by : Daniel Bar-Shalom

Download or read book Pediatric Formulations written by Daniel Bar-Shalom and published by Springer Science & Business Media. This book was released on 2014-01-30 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Essential Clinical Skills in Pediatrics

Author : Anwar Qais Saadoon
Publisher : Springer
ISBN 13 : 3319924265
Total Pages : 251 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Essential Clinical Skills in Pediatrics by : Anwar Qais Saadoon

Download or read book Essential Clinical Skills in Pediatrics written by Anwar Qais Saadoon and published by Springer. This book was released on 2018-09-03 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Translational Stem Cell Research

Author : Kristina Hug
Publisher : Springer Science & Business Media
ISBN 13 : 1607619598
Total Pages : 463 pages
Book Rating : 4.6/5 (76 download)

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Book Synopsis Translational Stem Cell Research by : Kristina Hug

Download or read book Translational Stem Cell Research written by Kristina Hug and published by Springer Science & Business Media. This book was released on 2010-12-25 with total page 463 pages. Available in PDF, EPUB and Kindle. Book excerpt: For many years, the ethical discussion surrounding human embryonic stem cell research has focused on the moral status of the embryo. This text takes a wider moral berth and focuses on numerous ethical, legal and social aspects involved in translating the results of stem cell research into diagnostic and therapeutic applications. Translational Stem Cell Research is broken into ten sections. It opens with an overview of the latest in stem cell research, focusing on specific diseases and the treatment of burn victims. Part II discusses the issues involved in the many steps from bench to bedside, ranging from first research in vitro to clinical trials. Part III covers scientific, regulatory and ethical challenges to basic research, and Part IV details issues regarding stem cell banks. Part V explores ethical, economic and strategic issues involved in collaboration between universities and industry, and Part VI addresses legal problems raised by patents on human stem-cell based inventions plus the extent to which there can be technological solutions to a moral dilemma. Part VII presents imaginative ways of communicating research to the general public and how to create conditions for a constructive dialogue. Part VIII probes psychosocial and cultural factors affecting judgment and decisions about translational stem cell research, and Part IX explores problems and procedures raised by an examination of the evaluation of stem cell research projects in research ethics committees. The book closes with a look into the future of translational stem cell research and stem cell-based therapeutic applications.

Drug Discovery and Development

Author : Omboon Vallisuta
Publisher : BoD – Books on Demand
ISBN 13 : 9535121286
Total Pages : 332 pages
Book Rating : 4.5/5 (351 download)

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Book Synopsis Drug Discovery and Development by : Omboon Vallisuta

Download or read book Drug Discovery and Development written by Omboon Vallisuta and published by BoD – Books on Demand. This book was released on 2015-06-03 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against Infectious Diseases; Advanced Methodology.

Considering the Patient in Pediatric Drug Development

Author : Klaus Rose
Publisher : Academic Press
ISBN 13 : 0128242051
Total Pages : 416 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Considering the Patient in Pediatric Drug Development by : Klaus Rose

Download or read book Considering the Patient in Pediatric Drug Development written by Klaus Rose and published by Academic Press. This book was released on 2020-11-19 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. - Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents - Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research - Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information

The Hands-on Guide to Practical Paediatrics

Author : Rebecca Hewitson
Publisher : John Wiley & Sons
ISBN 13 : 1118463528
Total Pages : 290 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis The Hands-on Guide to Practical Paediatrics by : Rebecca Hewitson

Download or read book The Hands-on Guide to Practical Paediatrics written by Rebecca Hewitson and published by John Wiley & Sons. This book was released on 2014-05-05 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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!

Contemporary Issues in Clinical Bioethics - Medical, Ethical and Legal Perspectives

Author : Kamil Hakan Dogan
Publisher : BoD – Books on Demand
ISBN 13 : 1837697159
Total Pages : 228 pages
Book Rating : 4.8/5 (376 download)

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Book Synopsis Contemporary Issues in Clinical Bioethics - Medical, Ethical and Legal Perspectives by : Kamil Hakan Dogan

Download or read book Contemporary Issues in Clinical Bioethics - Medical, Ethical and Legal Perspectives written by Kamil Hakan Dogan and published by BoD – Books on Demand. This book was released on 2024-05-15 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines challenges in bioethics from medical, ethical, legal, and industrial perspectives. A critical exchange of ideas from professionals in interdisciplinary fields allows all people to learn and benefit from their far-reaching insights gained through personal and professional experiences in medicine and research. Examining these complex issues, ranging from brain-computer interfaces to disabilities in health care to the determination of death to safe injection sites presents viable paradigms for all healthcare professionals who are being confronted with these issues today and in the future. The more we face these challenges directly, examine them critically, analyze them thoroughly, and debate them enthusiastically, the more knowledge will be gained and, hopefully, more lives will be saved.

Pediatric Clinical Pharmacology

Author : Hannsjörg W. Seyberth
Publisher : Springer Science & Business Media
ISBN 13 : 3642201954
Total Pages : 385 pages
Book Rating : 4.6/5 (422 download)

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Book Synopsis Pediatric Clinical Pharmacology by : Hannsjörg W. Seyberth

Download or read book Pediatric Clinical Pharmacology written by Hannsjörg W. Seyberth and published by Springer Science & Business Media. This book was released on 2011-09-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy.

Essentials of Translational Pediatric Drug Development

Author : Elke Gasthuys
Publisher : Elsevier
ISBN 13 : 0323904297
Total Pages : 732 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Essentials of Translational Pediatric Drug Development by : Elke Gasthuys

Download or read book Essentials of Translational Pediatric Drug Development written by Elke Gasthuys and published by Elsevier. This book was released on 2024-07-23 with total page 732 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development