Safety Efforts In Pediatric Drug Development
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Safety Efforts In Pediatric Drug Development
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Author : Conor D. Byrne
language : en
Publisher:
Release Date : 2010
Safety Efforts In Pediatric Drug Development written by Conor D. Byrne and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Child categories.
This book focuses on the safety efforts being implemented in paediatric drug development. Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only about one-third of the drugs that are prescribed for children have been studied and labelled for paediatric use. This has placed children taking drugs for which there have not been adequate paediatric drug studies at risk of being exposed to ineffective treatment or receiving incorrect dosing. In order to encourage the study of more drugs for paediatric use, Congress passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to provide marketing incentives to drug manufacturers for conducting paediatric drug studies. Drug manufacturers may obtain six months of additional market exclusivity for drugs on which they have conducted paediatric studies in accordance with pertinent law and regulations. This book also evaluates the impact of BPCA on labelling drugs for paediatric use and the process by which the labelling was changed, and illustrates the range of diseases treated by the drugs studied under BPCA. Additionally this book provides guidance on the role and timing of animal studies in the non-clinical safety evaluation of therapeutics intended for the treatment of paediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in paediatric patients and makes recommendations on non-clinical testing. This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access.
Pediatric Drug Development
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Author : Andrew E. Mulberg
language : en
Publisher: Wiley-Blackwell
Release Date : 2009-04-13
Pediatric Drug Development written by Andrew E. Mulberg and has been published by Wiley-Blackwell this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-04-13 with Medical categories.
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.
Pediatric Drug Development
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Author : Andrew E. Mulberg
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Pediatric Drug Development written by Andrew E. Mulberg and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Medical categories.
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.
Addressing The Barriers To Pediatric Drug Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2008-09-12
Addressing The Barriers To Pediatric Drug Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-09-12 with Medical categories.
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.
Promoting Safety Of Medicines For Children
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2007
Promoting Safety Of Medicines For Children written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.
Guide To Paediatric Drug Development And Clinical Research
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Author : Klaus Rose
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2010-01-01
Guide To Paediatric Drug Development And Clinical Research written by Klaus Rose and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-01 with Medical categories.
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.
Fundamentals Of Pediatric Drug Dosing
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Author : Iftekhar Mahmood
language : en
Publisher: Springer
Release Date : 2016-10-28
Fundamentals Of Pediatric Drug Dosing written by Iftekhar Mahmood and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-28 with Medical categories.
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.
Children And Drug Safety
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Author : Cynthia A Connolly
language : en
Publisher: Rutgers University Press
Release Date : 2018-05-11
Children And Drug Safety written by Cynthia A Connolly and has been published by Rutgers University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-11 with Health & Fitness categories.
Winner of the 2018 Arthur J. Viseltear Award from the Medical Care Section of the American Public Health Association Children and Drug Safety traces the development, use, and marketing of drugs for children in the twentieth century, a history that sits at the interface of the state, business, health care providers, parents, and children. This book illuminates the historical dimension of a clinical and policy issue with great contemporary significance—many of the drugs administered to children today have never been tested for safety and efficacy in the pediatric population. Each chapter of Children and Drug Safety engages with major turning points in pediatric drug development; themes of children’s risk, rights, protection and the evolving context of childhood; child-rearing; and family life in ways freighted with nuances of race, class, and gender. Cynthia A. Connolly charts the numerous attempts by Congress, the Food and Drug Administration, the American Academy of Pediatrics, and leading pediatric pharmacologists, scientists, clinicians, and parents to address a situation that all found untenable. Open access edition funded by the National Endowment for the Humanities. The text of this book is licensed under a Creative Commons Attribution NonCommercial-NoDerivatives 4.0 International License: https://creativecommons.org/licenses/by-nc-nd/4.0/
Safe And Effective Medicines For Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-10-13
Safe And Effective Medicines For Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-13 with Medical categories.
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.
Essentials Of Translational Pediatric Drug Development
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Author : Elke Gasthuys
language : en
Publisher: Elsevier
Release Date : 2024-07-23
Essentials Of Translational Pediatric Drug Development written by Elke Gasthuys and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-07-23 with Medical categories.
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
