Safety Efforts In Pediatric Drug Development

Download Safety Efforts In Pediatric Drug Development full books in PDF, epub, and Kindle. Read online Safety Efforts In Pediatric Drug Development ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Safety Efforts in Pediatric Drug Development

Author : Conor D. Byrne
Publisher :
ISBN 13 : 9781607415657
Total Pages : 0 pages
Book Rating : 4.4/5 (156 download)

DOWNLOAD NOW!

Book Synopsis Safety Efforts in Pediatric Drug Development by : Conor D. Byrne

Download or read book Safety Efforts in Pediatric Drug Development written by Conor D. Byrne and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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

DOWNLOAD NOW!

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.

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)

DOWNLOAD NOW!

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.

Pediatric Drug Development

Author : Andrew E. Mulberg
Publisher : John Wiley & Sons
ISBN 13 : 1118210433
Total Pages : 843 pages
Book Rating : 4.1/5 (182 download)

DOWNLOAD NOW!

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 2011-09-20 with total page 843 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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)

DOWNLOAD NOW!

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.

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)

DOWNLOAD NOW!

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.

Fundamentals of Pediatric Drug Dosing

Author : Iftekhar Mahmood
Publisher : Springer
ISBN 13 : 3319437542
Total Pages : 146 pages
Book Rating : 4.3/5 (194 download)

DOWNLOAD NOW!

Book Synopsis Fundamentals of Pediatric Drug Dosing by : Iftekhar Mahmood

Download or read book Fundamentals of Pediatric Drug Dosing written by Iftekhar Mahmood and published by Springer. This book was released on 2016-10-28 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Programs Affecting Safety and Innovation in Pediatric Therapies

Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher :
ISBN 13 :
Total Pages : 160 pages
Book Rating : 4.0/5 ( download)

DOWNLOAD NOW!

Book Synopsis Programs Affecting Safety and Innovation in Pediatric Therapies by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Download or read book Programs Affecting Safety and Innovation in Pediatric Therapies written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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)

DOWNLOAD NOW!

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.

Children and Drug Safety

Author : Cynthia A Connolly
Publisher : Rutgers University Press
ISBN 13 : 0813575230
Total Pages : 339 pages
Book Rating : 4.8/5 (135 download)

DOWNLOAD NOW!

Book Synopsis Children and Drug Safety by : Cynthia A Connolly

Download or read book Children and Drug Safety written by Cynthia A Connolly and published by Rutgers University Press. This book was released on 2018-05-11 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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/

Children and Drug Safety

Author : Cynthia A Connolly
Publisher : Rutgers University Press
ISBN 13 : 0813563895
Total Pages : 261 pages
Book Rating : 4.8/5 (135 download)

DOWNLOAD NOW!

Book Synopsis Children and Drug Safety by : Cynthia A Connolly

Download or read book Children and Drug Safety written by Cynthia A Connolly and published by Rutgers University Press. This book was released on 2018-05-11 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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/

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)

DOWNLOAD NOW!

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

Promoting Safety of Medicines for Children

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241563435
Total Pages : 65 pages
Book Rating : 4.2/5 (415 download)

DOWNLOAD NOW!

Book Synopsis Promoting Safety of Medicines for Children by : World Health Organization

Download or read book Promoting Safety of Medicines for Children written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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)

DOWNLOAD NOW!

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.

Drug Safety Evaluation

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 1119097401
Total Pages : 918 pages
Book Rating : 4.1/5 (19 download)

DOWNLOAD NOW!

Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Drug Development and Rare Pediatric Diseases

Author : Frederick Johnston
Publisher : Nova Biomedical Books
ISBN 13 : 9781536102284
Total Pages : 122 pages
Book Rating : 4.1/5 (22 download)

DOWNLOAD NOW!

Book Synopsis Drug Development and Rare Pediatric Diseases by : Frederick Johnston

Download or read book Drug Development and Rare Pediatric Diseases written by Frederick Johnston and published by Nova Biomedical Books. This book was released on 2021-08 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past few decades, a number of legislative actions have been taken to encourage the development of therapies to treat people affected by rare diseases and to encourage therapies for pediatric patients. During this same time period, the Food and Drug Administration (FDA) has invested substantial effort in support of these same goals. As described in this book, recent legislative actions have prompted new initiatives. Continuing the response to the laws' specific requirements and FDA's commitment under PDUFA, this book includes input from the public and FDA and discusses the many complex issues involved in medical product development for people with rare diseases. Following a brief overview of both legislative and FDA efforts over the years to foster development of therapies for these patients, the book summarizes the three days of the public meeting and presents FDA's strategic plan for accelerating the development of the urgently needed therapies for pediatric rare diseases.

Ensuring Safe Medicines and Medical Devices for Children

Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher :
ISBN 13 :
Total Pages : 64 pages
Book Rating : 4.0/5 ( download)

DOWNLOAD NOW!

Book Synopsis Ensuring Safe Medicines and Medical Devices for Children by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions

Download or read book Ensuring Safe Medicines and Medical Devices for Children written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2008 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: