Considering the Patient in Pediatric Drug Development

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

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.

Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects provides a practical guide and overview of the ethical, scientific and regulatory aspects of clinical research in pediatric psychopharmacology, also discussing practical points to consider when developing clinical research in this field. The book is ideal for professionals involved in clinical research in pediatric psychopharmacology, i.e., including, but not limited to pediatricians, health care professionals, researchers, investigators, pharmaceutical company personals and potentially ethics committee members. Topics discussed include the role of patient organization and advocacy groups in research, the role of families and patients: ‘should I involve my kid in clinical research, and historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. Covers both theoretical and practical aspects of clinical research in paediatric psychopharmacology Approaches the topic from different angles from the regulatory framework to the patient perspective Discusses ethical and safety considerations for research in paediatric psychopharmacology Offers future perspective for paediatric development

Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not ‘small adults’, and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

A Doody's Core Title 2012 Thoroughly updated and expanded, the new edition of the classic comprehensive reference on pediatric rehabilitation brings together specialists from the various wings of the pediatric rehabilitation community. This market-leading text covers everything from basic examination and psychological assessment to electrodiagnosis, therapeutic exercise, orthotics and assistive devices, and in-depth clinical management of the full range of childhood disabilities and injuries. Features include: Expanded new edition of Dr. Gabriella Molnars pioneering pediatric rehabilitation text Comprehensive coverage of all areas, with up-to-date information on therapy, exercise physiology, CAM, cancer, obesity, and joint replacement Clinical emphasis throughout Multi-specialty expert authorship

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.

Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.

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.

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.

To address the growing complexities of childhood cancer, Nathan and Oski’s Hematology and Oncology of Infancy and Childhood has now been separated into two distinct volumes. With this volume devoted strictly to pediatric oncology, and another to pediatric hematology, you will be on the cutting edge of these two fields. This exciting new, full-color reference provides you with the most comprehensive, authoritative, up-to-date information for diagnosing and treating children with cancer. It brings together the pathophysiology of disease with detailed clinical guidance on diagnosis and management for the full range of childhood cancers, including aspects important in optimal supportive care. Written by the leading names in pediatric oncology, this resource is an essential tool for all who care for pediatric cancer patients. Offers comprehensive coverage of all pediatric cancers, including less common tumors, making this the most complete guide to pediatric cancer. Covers emerging research developments in cancer biology and therapeutics, both globally and in specific pediatric tumors. Includes a section on supportive care in pediatric oncology, written by authors who represent the critical subdisciplines involved in this important aspect of pediatric oncology. Uses many boxes, graphs, and tables to highlight complex clinical diagnostic and management guidelines. Presents a full-color design that includes clear illustrative examples of the relevant pathology and clinical issues, for quick access to the answers you need. Incorporates the codified WHO classification for all lymphomas and leukemias.

Textbook of Pediatric Rheumatology examines the full spectrum of rheumatologic diseases and non-rheumatologic musculoskeletal disorders in children and adolescents, detailing the presentation, differential diagnosis, course, management, and prognosis of every major condition. Drs. James T. Cassidy, Ross E. Petty, Ronald M. Laxer, and Carol B. Lindsley discuss recent developments in diagnosis, treatment, genetics, immunology, imaging, and more. Diagnose and treat effectively through exhaustive reviews of the complex symptoms and signs and lab abnormalities that characterize these clinical disorders. Choose treatment protocols based on the best scientific evidence available today. Apply the knowledge and experience of the leading experts in the field. Keep current with coverage of new topics including macrophage activation syndrome, pediatric sarcoidosis, uveitis, imaging, and occupational and physical therapy. Tap into detailed discussions of recent advances in the field, new research on the immunologic mechanisms of inflammatory disease, and new developments on biologic treatments for arthritis in ten new chapters. Master complex concepts and key techniques with a full-color design and full-color illustrations.

Covers the general principles of pediatric pharmacology from a clinical perspective. Over 80 distinguished authorities discuss drugs and pregnancy, with special emphasis on maternal-fetal medicine, drugs and the infant, child, and adolescent, as well as specific drugs and adverse drug effects.

This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.

Implantable cardioverter-defibrillators (ICDs) are electronic devices installed in the chest to prevent sudden death caused by abnormally fast heart rhythms. Cardiac electrophysiologists are the physicians usually responsible for implanting and maintaining these devices. The technology for ICDs is rapidly evolving, and the articles in this issue will help electrophysiologists to keep up to date with the current generation of ICDs, including selection of patients who are appropriate for the device, monitoring patients after the device is implanted, and troubleshooting problems with the device.

Considered the definitive source in its field for over 35 years, Endocrinology: Adult and Pediatric, has been thoroughly updated to reflect today's recent advances in adult and pediatric endocrinology. Unique perspectives from a team of trusted, world-renowned experts ensure this medical reference book remains the most highly-regarded text in the field. Make the best clinical decisions with an enhanced emphasis on evidence-based practice and expert opinions on treatment strategies. Zero in on the most relevant and useful references with the aid of a more focused, concise bibliography. Locate information quickly, while still getting the complete coverage you expect. Expanded coverage for key topics such as pediatric endocrinology and obesity mechanisms and treatment, in addition to today's hot topics in endocrinology, including endocrine disruptors, bariatric surgery, androgen deficiency, genetic causes of obesity, endocrine rhythms, and the use of tyrosine kinase inhibitors in thyroid cancer. New content addressing the latest advances in testosterone and estrogen replacement, as well as the new causes of calcium and phosphate disorders, new molecular causes of endocrine cancers, new genetic causes of reproductive disorders, and more. Updated clinical guidelines for diabetes, lipid disorders, obesity management, osteoporosis, and more, as well as essential treatment updates for the medical management of acromegaly, Cushing's Disease, hypercalcemia, and diabetes mellitus. New Key Points provide snapshots of what to expect in each chapter, or serve as a refresher of what you just read. Consult this title on your favorite e-reader.

"This book presents a stimulating and up-to-date overview of the context of education in SEN and suggests how educators can address special needs most effectively by keeping in mind an image of the development of the whole child. The editors have assembled an impressive range of thought-provoking contributions to the ongoing debate on the actual, the possible and the ideal responses that our education system makes or could make to the needs of its most vulnerable students." Tony Cline, Educational Psychology Group, University College London, UK. "This book provides readers with a fresh, often incisive approach to many perennial issues in education. These include but are not limited to socio-political agendas in inclusion, labelling, learners' self esteem and the delicate balance between different specialists within school systems that must be achieved in the best interest of the child with or without special educational needs and disabilities. Although written for a UK readership, the editors have ensured that the content of most chapters transcends national and systems boundaries with a healthy balance between psychological / educational theory and its real world application in contexts that may not be instantly responsive to the child's changing needs." Dr Victor Martinelli, University of Malta, Malta. "This book provides a welcome overview and commentary on current complex issues and problems affecting all those with an interest in children and young people with special educational needs. Ranging, as it does, from matters surrounding individuals such as labelling, therapeutic work and self-esteem to wider political, historical and socio- cultural influences, it provides the reader with a challenging, informed and critical set of perspectives. Its strength is the manner in which it tackles complex issues, providing thought-provoking views for those well versed in the world of special educational needs but also ensuring clear, comprehensive background information for novice readers of this topic. This book is an excellent compilation of relevant contemporary pieces thoughtfully woven together by highly skilled, well-placed editors." Jane Leadbetter, University of Birmingham, UK. This thought-provoking and accessible book provides an overview of key issues in the education of children with Special Educational Needs and Disabilities. Written by highly experienced practitioners and educationalists, the book explores a range of approaches for working with this diverse group of learners and invites you to consider your possible responses. The book begins with an historical overview of Special Educational Needs and Disabilities and a critical guide to current policy. The contributors then expertly explore and summarise many of the fascinating topics which arise in practice and scholarly research in this area, including: Ethical and practical implications of labelling children and young people with forms of special educational needs or disability The role of special schools, particularly in light of enduring debates about inclusion/exclusion What increased student participation, student voice and other facets of a democratic classroom mean for students with Special Educational Needs and Disabilities The contributions psychology can make to developing and enriching educational practice Understanding 'behaviour' in relation to children and young people with Special Educational Needs and Disabilities Case studies are used to illustrate these discussions and the book includes suggested protocols for good practice throughout. Throughout the book the reader is asked to reflect on the issues presented and come to their own decisions about what represents good practice in their setting.The journey concludes with a look at a possible 'ideal' school or educational setting for children with Special Educational Needs and Disabilities. Contemporary Issues in Special Educational Needs is an invaluable guide for trainee and qualified teachers, learning support staff, SENCO's, local authority officers, educational consultants and educational psychologists.

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

nurse for life – electronic access only Get to all of the high-quality content from Elsevier faster than ever! Your favourite textbooks are now available as e-books through nurse for life, allowing you to: Electronically search the book Create and share notes and highlights Save time with automatic referencing Load it up and change the way you learn! What do I get? You will be emailed a PIN code that will give you perpetual access to the electronic version of the book through nurse for life. Book description This title is directed primarily towards health care professionals outside of the United States. Covering the full age and specialty spectrum this text brings together for the first time, individual chapters from among the most respected children's nurses. This textbook is rooted in child-centred health care within a family context and draws upon best contemporary practice throughout the UK and further afield. This innovative text harnesses new design parameters in enquiry-based/problem-based learning, providing up-to-date information on a wide range of topics. In an exciting addition each chapter offers readers additional material on an Evolve website. Full Microsoft PowerPoint presentations augment the written chapters and provide extra information that includes case studies, moving image, photographs and text. Each chapter offers readers additional material on an Evolve website. Full Microsoft PowerPoint presentations augment the written chapters and provide extra information that includes case studies, moving image, photographs and text. Aims, objectives, learning outcomes, a summary box in each chapter and key points assist learning and understanding Professional conversation boxes enliven the text on the page and make it more interesting to dip into Suggestions for seminar discussion topics to help teachers Case studies help to relate theory to practice Prompts to promote reflective practice Activity boxes/suggested visits Evidence based practice boxes which highlight key research studies, annotated bibliographies including details of web-sites and full contemporary references to the evidence base Resource lists including recommended web-site addresses

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.