Chapter 35: The Importance of Geographic Differences in Pediatric Clinical Trials

Chapter 35: The Importance of Geographic Differences in Pediatric Clinical Trials

Author: Andrew E. Mulberg

Publisher: Wiley-Blackwell

Published: 2009-08-13

Total Pages: 683

ISBN-13: 9780470582398

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The first comprehensive treatmentof this vital topicFor decades, the specific needs of infants, children, and adolescents have been largely ignored in the drug development process, and healthcare providers have most often had to make do with pediatric dosing of drugs that were developed and intended for adults. Now, an awareness of the differences between the pediatric patient and the adult patient have begun to be realized and addressed by the pharmaceutical and wider healthcare industries, as well as the governmental and regulatory bodies that sanction the development and testing of drugs for children.This is the first book to provide a comprehensive treatment of pediatric drug development. Written by a team of experts, it provides industry, academia, and governmental agencies with an understanding of how to properly develop drugs for children without compromising business objectives. The authors address the scientific differences between the pediatric and adult subject in the development of pharmaceutical products. They discuss and consider: ethics--from product concept to production; specific medical needs of children; business rationale for the proper development of drugs for children; and the technical feasibility of studies and processes that are necessary for a proper pediatric drug development program.The book clearly explains the challenges and opportunities facing the entire healthcare community as it strives to improve the health of children worldwide. It demonstrates how these approaches will benefit all stakeholders and, ultimately, provide better and safer drugs for the pediatric population at large.This timely new work is essential reading for academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in pediatric drug development. It also serves as an important textbook for students in pharmacy, science, and medicine courses.


Pediatric Drug Development

Pediatric Drug Development

Author: Andrew E. Mulberg

Publisher: John Wiley & Sons

Published: 2011-09-20

Total Pages: 843

ISBN-13: 1118210433

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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.


Retina

Retina

Author: David R. Hinton

Publisher: Elsevier Health Sciences

Published: 2005-09-21

Total Pages: 2744

ISBN-13: 0323025986

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Praised by JAMA as "The most complete description of the development, structure, function, pathophysiology, and treatment of the retina and its diseases to be found anywhere," this monumental three-volume work puts all of today's scientific and clinical knowledge of the retina at readers' fingertips. The New Edition has been comprehensively updated and reorganized to reflect all of the very latest scientific and genetic discoveries, diagnostic imaging methods, drug therapies, treatment recommendations, and surgical techniques. The result is an indispensable reference and diagnostic tool for generalists and specialists alike. Delivers the editorial expertise of four highly respected authorities, as well as contributions from internationally recognized leaders in visual science, ophthalmology, and vitreoretinal studies. Presents more than 3,400 superb illustrations (2,200 in full color) that capture all forms of retinal disease from every perspective. Offers the very latest information on the genetic basis of retinal disease, diagnostic retinal imaging, photodynamic therapy, and age-related macular degeneration. Examines the most recent advances in diagnostic indocyanine green angiography � optical coherence tomography (OCT) and quantitative fluoroscein angiography � macular translocation with 360� peripheral retinectomy � surgery for diffuse macular edema due to multiple causes, including proliferative vitreoretinopathy � artificial vision � and much more. Features a completely restructured section on age-related macular degeneration that includes epidemiology and risk factors � prophylaxis and prevention knowledge gained from large clinical trials like AREDS � proven and experimental treatments for AMD � and pharmacotherapy. Incorporates a multitude of new full-color images, 2200 in all.


Model Rules of Professional Conduct

Model Rules of Professional Conduct

Author: American Bar Association. House of Delegates

Publisher: American Bar Association

Published: 2007

Total Pages: 216

ISBN-13: 9781590318737

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The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.


Hunter's Tropical Medicine and Emerging Infectious Diseases E-Book

Hunter's Tropical Medicine and Emerging Infectious Diseases E-Book

Author: Edward T Ryan

Publisher: Elsevier Health Sciences

Published: 2019-03-25

Total Pages: 1264

ISBN-13: 0323625509

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New emerging diseases, new diagnostic modalities for resource-poor settings, new vaccine schedules ... all significant, recent developments in the fast-changing field of tropical medicine. Hunter’s Tropical Medicine and Emerging Infectious Diseases, 10th Edition, keeps you up to date with everything from infectious diseases and environmental issues through poisoning and toxicology, animal injuries, and nutritional and micronutrient deficiencies that result from traveling to tropical or subtropical regions. This comprehensive resource provides authoritative clinical guidance, useful statistics, and chapters covering organs, skills, and services, as well as traditional pathogen-based content. You’ll get a full understanding of how to recognize and treat these unique health issues, no matter how widespread or difficult to control. Includes important updates on malaria, leishmaniasis, tuberculosis and HIV, as well as coverage of Ebola, Zika virus, Chikungunya, and other emerging pathogens. Provides new vaccine schedules and information on implementation. Features five all-new chapters: Neglected Tropical Diseases: Public Health Control Programs and Mass Drug Administration; Health System and Health Care Delivery; Zika; Medical Entomology; and Vector Control – as well as 250 new images throughout. Presents the common characteristics and methods of transmission for each tropical disease, as well as the applicable diagnosis, treatment, control, and disease prevention techniques. Contains skills-based chapters such as dentistry, neonatal pediatrics and ICMI, and surgery in the tropics, and service-based chapters such as transfusion in resource-poor settings, microbiology, and imaging. Discusses maladies such as delusional parasitosis that are often seen in returning travelers, including those making international adoptions, transplant patients, medical tourists, and more.


Pediatric Respiratory Medicine E-Book

Pediatric Respiratory Medicine E-Book

Author: Lynn M. Taussig

Publisher: Elsevier Health Sciences

Published: 2008-04-09

Total Pages: 1400

ISBN-13: 0323070728

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Featuring the work of recognized worldwide experts, this user-friendly text presents the most current scientific information, diagnostic approaches, and management strategies for the care of children with acute and chronic respiratory diseases. A consistent chapter format enables you to rapidly and effortlessly locate the most current protocols on manifestations, etiologies, triggers, approaches to treatment, complications, and preventative strategies. And, a bonus website—new to this edition—features all of the book’s illustrations and extensive reference lists for each chapter in electronic format for your personal use. Includes guidance on differential diagnosis to help you determine which disease or condition your patient may have. Uses extensive color-coded algorithms to facilitate quick diagnosis, management, and treatment decisions. Organizes material to parallel your clinical decision making process. Provides expert guidance on what diagnostic tests to order for each patient—and how to interpret the results. Presents important “take home concepts within each chapter to help you recall clinical pearls. Includes the most need-to-know basic science, focusing on providing clear implications for patient care. Includes a separate website with all of the images from the text and extensive reference lists—downloadable for your personal use. Provides the latest scientific information and diagnostic and management strategies for the care of children with respiratory illnesses. Features a new, functional four-color design to help you identify important information quickly and differentiate between essential and extraneous material. Presents cutting-edge coverage with new information on the biology of, and the influences on, the respiratory system during childhood, as well as the diagnosis and management of both common (ie, wheezing infant, cystic fibrosis, tuberculosis) and less common (ie, SARS, chest tumors, collagen vascular diseases, Familial Mediterranean Fever) conditions.


Nathan and Oski's Hematology of Infancy and Childhood E-Book

Nathan and Oski's Hematology of Infancy and Childhood E-Book

Author: Stuart H. Orkin

Publisher: Elsevier Health Sciences

Published: 2008-12-16

Total Pages: 1868

ISBN-13: 1437721303

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To address the exponential growth in the fields of pediatric hematology and oncology, this classic reference has been separated into two distinct volumes. With this volume, devoted strictly to pediatric hematology, and another to pediatric oncology, you’ll keep you on the cutting-edge of these two specialties. The completely revised 7th edition of Nathan and Oski’s Hematology of Infancy and Childhood is now in full color, and provides you with the most comprehensive, authoritative, up-to-date information for diagnosing and treating children with hematologic disorders. It brings together the pathophysiology of disease with detailed clinical guidance on diagnosis and management for the full range of blood diseases that you encounter in everyday practice. Written by the leading names in pediatric hematology, this resource is an essential tool for anyone involved in caring for children with hematologic disorders. Balances summaries of relevant pathophysiology with clear, practical clinical guidance to help you thoroughly understand the underlying science of diseases. Offers comprehensive coverage of all hematologic disorders, including newly recognized ones, along with the latest breakthroughs in diagnosis and management. Uses many boxes, graphs, and tables to highlight complex clinical diagnostic and management guidelines at a glance. Presents an all-new full-color design that includes clear illustrative examples of relevant science and clinical problems for quick access to the answers you need.


Burns' Pediatric Primary Care - E-Book

Burns' Pediatric Primary Care - E-Book

Author: Dawn Lee Garzon

Publisher: Elsevier Health Sciences

Published: 2023-11-27

Total Pages: 1026

ISBN-13: 0443110425

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Build a comprehensive foundation in children’s primary care. Burns' Pediatric Primary Care, 8th Edition, covers the full spectrum of health conditions seen in primary care pediatrics, emphasizing both prevention and management. This in-depth, evidence-based textbook is the only one on the market written from the unique perspective of the Nurse Practitioner. It guides you through assessing, managing, and preventing health problems in children from infancy through adolescence. Key topics include developmental theory, issues of daily living, the health status of children today, and diversity and cultural considerations. Updated content throughout reflects the latest research evidence, national and international protocols, and standardized guidelines. Additionally, this edition includes three new chapters on topics such as palliative care; inclusivity, equity, diversity, and justice; and child maltreatment. Comprehensive content provides a complete foundation in the primary care of children from the unique perspective of the Nurse Practitioner and covers the full spectrum of health conditions seen in the primary care of children, emphasizing both prevention and management. In-depth guidance covers assessing and managing pediatric health problems in patients from infancy through adolescence. Highlights indicate situations that require urgent action, consultation, or referral for additional treatment outside the primary care setting. Coverage of activities related to every child’s daily living, such as nutrition and toilet training, explores issues that could lead to health problems unless appropriate education and guidance are given. Algorithms throughout the book provide a concise overview of the evaluation and management of common disorders. Resources for providers and families are included throughout the text for further information. Expert editor team is well-versed in the scope of practice and knowledge base of Pediatric Nurse Practitioners (PNPs) and Family Nurse Practitioners (FNPs).


Transforming the Workforce for Children Birth Through Age 8

Transforming the Workforce for Children Birth Through Age 8

Author: National Research Council

Publisher: National Academies Press

Published: 2015-07-23

Total Pages: 587

ISBN-13: 0309324882

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Children are already learning at birth, and they develop and learn at a rapid pace in their early years. This provides a critical foundation for lifelong progress, and the adults who provide for the care and the education of young children bear a great responsibility for their health, development, and learning. Despite the fact that they share the same objective - to nurture young children and secure their future success - the various practitioners who contribute to the care and the education of children from birth through age 8 are not acknowledged as a workforce unified by the common knowledge and competencies needed to do their jobs well. Transforming the Workforce for Children Birth Through Age 8 explores the science of child development, particularly looking at implications for the professionals who work with children. This report examines the current capacities and practices of the workforce, the settings in which they work, the policies and infrastructure that set qualifications and provide professional learning, and the government agencies and other funders who support and oversee these systems. This book then makes recommendations to improve the quality of professional practice and the practice environment for care and education professionals. These detailed recommendations create a blueprint for action that builds on a unifying foundation of child development and early learning, shared knowledge and competencies for care and education professionals, and principles for effective professional learning. Young children thrive and learn best when they have secure, positive relationships with adults who are knowledgeable about how to support their development and learning and are responsive to their individual progress. Transforming the Workforce for Children Birth Through Age 8 offers guidance on system changes to improve the quality of professional practice, specific actions to improve professional learning systems and workforce development, and research to continue to build the knowledge base in ways that will directly advance and inform future actions. The recommendations of this book provide an opportunity to improve the quality of the care and the education that children receive, and ultimately improve outcomes for children.


Understanding Information Retrieval Systems

Understanding Information Retrieval Systems

Author: Marcia J. Bates

Publisher: CRC Press

Published: 2011-12-20

Total Pages: 752

ISBN-13: 1439891990

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In order to be effective for their users, information retrieval (IR) systems should be adapted to the specific needs of particular environments. The huge and growing array of types of information retrieval systems in use today is on display in Understanding Information Retrieval Systems: Management, Types, and Standards, which addresses over 20 typ