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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309178657
Category : Medical
Languages : en
Pages : 64
Get Book Here
Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309225493
Category : Medical
Languages : en
Pages : 432
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Book Description
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author: Klaus Rose
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805593627
Category : Medical
Languages : en
Pages : 240
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Book Description
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Author: Klaus Rose
Publisher: Academic Press
ISBN: 0128238887
Category : Medical
Languages : en
Pages : 414
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Book Description
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.
Author: Chris J. van Boxtel
Publisher: John Wiley & Sons
ISBN: 9780471899273
Category : Medical
Languages : en
Pages : 738
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Book Description
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.
Author: Raymond A. Huml
Publisher: Springer Nature
ISBN: 3030786056
Category : Medical
Languages : en
Pages : 418
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Book Description
This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.
Author: Nunzio Denora
Publisher: MDPI
ISBN: 303650740X
Category : Science
Languages : en
Pages : 205
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309183642
Category : Medical
Languages : en
Pages : 135
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Book Description
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.
Author: Sumner J. Yaffe
Publisher: Lippincott Williams & Wilkins
ISBN: 0781795389
Category : Medical
Languages : en
Pages : 1072
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Book Description
"Neonatal and Pediatric Pharmacology offers guidelines for safe, effective, and rational drug therapy in newborns, children and adolescents. The book provides relevant and useful data on the molecular, physiologic, biochemical, and pharmacologic mechanisms of drug action and therapy in this population. The authors identify areas of innovative basic and translational research necessary for the continuing evaluation and development of drugs for the fetus, newborns, children and adolescents. Neonatal and Pediatric Pharmacology is is a valuable reference for all health care professionals who treat the fetus, newborns, children, and adolescents, including neonatologists, nurses, pediatricians, general practitioners, students, obstetricians, perinatologists, surgeons and allied health professionals. It will be useful anytime during the day and especially in the middle of the night when knowledge of appropriate indications, safe and effective use, dosage, and therapeutic regimen for a certain drug or molecular entity is immediately needed. The book is also directed to those involved in basic, clinical, and other academic pharmacological research, the pharmaceutical industry, and regulatory agencies dealing with drug and therapeutic developments for this population. Those teaching pharmacology and therapeutics will find this compilation of information extremely useful in preparing teaching materials"--Provided by publisher.
Author: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20
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Book Description
