Considering The Patient In Pediatric Drug Development

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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

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.

Addressing the Barriers to Pediatric Drug Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309178657
Total Pages : 64 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Addressing the Barriers to Pediatric Drug Development by : Institute of Medicine

Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Paediatric Formulation

Author : Nunzio Denora
Publisher : MDPI
ISBN 13 : 303650740X
Total Pages : 205 pages
Book Rating : 4.0/5 (365 download)

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Book Synopsis Paediatric Formulation by : Nunzio Denora

Download or read book Paediatric Formulation written by Nunzio Denora and published by MDPI. This book was released on 2021-09-02 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of paediatric medicines can be challenging since this is a different patient population with specific needs. A medicine designed for use in paediatric patients must consider the following aspects: patient population variability; the need for dose flexibility; route of administration; patient compliance; excipient tolerability. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Globally, about 75% of drugs do not carry regulatory approval for use in children; worldwide, many medications prescribed for the treatment of paediatric diseases are used off-label, and less than 20% of package inserts have sufficient information for treating children. This book provides an update on both state-of-the-art methodology and operational challenges in paediatric formulation design and development. It aims at re-evaluating what is needed for more progress in the design and development of age-appropriate treatments for paediatric diseases, focusing on: formulation development; drug delivery design; efficacy, safety, and tolerability of drugs and excipients.

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.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498511
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

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.

Rational Therapeutics for Infants and Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309183642
Total Pages : 135 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rational Therapeutics for Infants and Children by : Institute of Medicine

Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

Pediatric Drug Development

Author : Andrew E. Mulberg
Publisher : John Wiley & Sons
ISBN 13 : 1118312058
Total Pages : 782 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Pediatric Drug Development by : Andrew E. Mulberg

Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

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.

Drug Benefits and Risks

Author : Chris J. van Boxtel
Publisher : John Wiley & Sons
ISBN 13 : 9780471899273
Total Pages : 738 pages
Book Rating : 4.8/5 (992 download)

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Book Synopsis Drug Benefits and Risks by : Chris J. van Boxtel

Download or read book Drug Benefits and Risks written by Chris J. van Boxtel and published by John Wiley & Sons. This book was released on 2001-11-28 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

General Considerations for the Clinical Evaluation of Drugs

Author : United States. Food and Drug Administration. Bureau of Drugs
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis General Considerations for the Clinical Evaluation of Drugs by : United States. Food and Drug Administration. Bureau of Drugs

Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pediatric Decision-Making Strategies E-Book

Author : Albert J. Pomeranz
Publisher : Elsevier Health Sciences
ISBN 13 : 0323353851
Total Pages : 371 pages
Book Rating : 4.3/5 (233 download)

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Book Synopsis Pediatric Decision-Making Strategies E-Book by : Albert J. Pomeranz

Download or read book Pediatric Decision-Making Strategies E-Book written by Albert J. Pomeranz and published by Elsevier Health Sciences. This book was released on 2015-01-08 with total page 371 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed to accompany Nelson Textbook of Pediatrics and Nelson Essentials of Pediatrics, Pediatric Decision-Making Strategies is a concise, user-friendly reference uses a unique algorithmic approach to facilitate diagnosis, testing, and basic treatment of common pediatric disorders. For any given symptom, an algorithm guides the reader through the appropriate investigative procedures and lab tests to reach definitive diagnoses. An updated format that enhances usability makes this medical reference book a must-have for medical students, residents, and practitioners treating pediatric patients. - Explore concise, focused, and updated algorithms that cover the most common pediatric problems. - Gain imperative knowledge from an expert author team that includes Dr. Robert M. Kliegman (of the Nelson line of textbooks), as well as references to related chapters in both Nelson Textbook of Pediatrics and Nelson Essentials of Pediatrics. - Quickly access important information with a new standard format and trim size for practicality and usability. - Expert Consult eBook version included with purchase. This enhanced eBook experience allows you to search all of the text, figures, algorithms, and references from the book on a variety of devices.

The Harriet Lane Handbook

Author : Harriet Lane Service
Publisher :
ISBN 13 : 9780323473736
Total Pages : pages
Book Rating : 4.4/5 (737 download)

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Book Synopsis The Harriet Lane Handbook by : Harriet Lane Service

Download or read book The Harriet Lane Handbook written by Harriet Lane Service and published by . This book was released on 2017-05-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Vessel Health and Preservation: The Right Approach for Vascular Access

Author : Nancy L. Moureau
Publisher : Springer
ISBN 13 : 3030031497
Total Pages : 303 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Vessel Health and Preservation: The Right Approach for Vascular Access by : Nancy L. Moureau

Download or read book Vessel Health and Preservation: The Right Approach for Vascular Access written by Nancy L. Moureau and published by Springer. This book was released on 2019-06-10 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Open access book offers updated and revised information on vessel health and preservation (VHP), a model concept first published in poster form in 2008 and in JVA in 2012, which has received a great deal of attention, especially in the US, UK and Australia. The book presents a model and a new way of thinking applied to vascular access and administration of intravenous treatment, and shows how establishing and maintaining a route of access to the bloodstream is essential for patients in acute care today. Until now, little thought has been given to an intentional process to guide selection, insertion and management of vascular access devices (VADs) and by default actions are based on crisis management when a quickly selected VAD fails. The book details how VHP establishes a framework or pathway model for each step of the patient experience, intentionally guiding, improving and eliminating risk when possible. The evidence points to the fact that reducing fragmentation, establishing a pathway, and teaching the process to all stakeholders reduces complications with intravenous therapy, improves efficiency and diminishes cost. As such this book appeals to bedside nurses, physicians and other health professionals.