Safety Efforts In Pediatric Drug Development

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Safety Efforts in Pediatric Drug Development

Conor D. Byrne
Safety Efforts in Pediatric Drug Development Book PDF

Author : Conor D. Byrne
Publisher : Unknown
Page : 0 pages
File Size : 44,9 Mb
Release : 2010
Category : Child
ISBN : 1607415658

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Safety Efforts in Pediatric Drug Development by Conor D. Byrne Pdf

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.

Safe and Effective Medicines for Children

Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Safe and Effective Medicines for Children Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publisher : National Academies Press
Page : 432 pages
File Size : 50,6 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

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Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf

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

Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Addressing the Barriers to Pediatric Drug Development Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 64 pages
File Size : 55,6 Mb
Release : 2008-08-12
Category : Medical
ISBN : 9780309178655

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Addressing the Barriers to Pediatric Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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

Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
Pediatric Drug Development Book PDF

Author : Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
Publisher : John Wiley & Sons
Page : 843 pages
File Size : 52,8 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210437

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Pediatric Drug Development by Andrew E. Mulberg,Steven A. Silber,John N. van den Anker Pdf

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

Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Pediatric Drug Development Book PDF

Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publisher : John Wiley & Sons
Page : 782 pages
File Size : 53,6 Mb
Release : 2013-05-20
Category : Medical
ISBN : 9781118312056

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Pediatric Drug Development by Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis Pdf

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.

Improving Medicines for Children in Canada

The Expert Panel on Therapeutic Products for Infants, Children, and Youth,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Improving Medicines for Children in Canada Book PDF

Author : The Expert Panel on Therapeutic Products for Infants, Children, and Youth,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher : Council of CanadianAcademies
Page : 292 pages
File Size : 52,8 Mb
Release : 2014-09
Category : Medical
ISBN : 9781926558851

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Improving Medicines for Children in Canada by The Expert Panel on Therapeutic Products for Infants, Children, and Youth,Council of Canadian Academies: The Expert Panel on Therapeutic Products for Infants, Children, and Youth Pdf

"Recognizing the importance of developing safe and effective medicines specifically for children, the Minister of Health, on behalf of Health Canada, asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment of the state of research and regulations leading to the approval of therapeutic products for children, in Canada and abroad. Specifically, this assessment examines the following questions: What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labelled as therapies for infants, children, and youth? How does human development from infancy to youth alter clinical pharmacology and therefore inform pediatric drug investigations? What are best practices to ethically conduct scientifically sound but adaptive drug studies to confirm the safety and effectiveness of drugs for infants, children, and youth? When the participation of infants, children, and youth in drug studies is not feasible, what are the best practices to confirm drug safety and effectiveness in these populations? What are Canada's strengths to contribute to global pharmacovigilance efforts for drugs that may benefit infants, children, and youth?"--Executive summary.

Children and Drug Safety

Cynthia A Connolly
Children and Drug Safety Book PDF

Author : Cynthia A Connolly
Publisher : Rutgers University Press
Page : 261 pages
File Size : 53,8 Mb
Release : 2018-05-11
Category : Health & Fitness
ISBN : 9780813563893

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Children and Drug Safety by Cynthia A Connolly Pdf

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/

Promoting Safety of Medicines for Children

World Health Organization
Promoting Safety of Medicines for Children Book PDF

Author : World Health Organization
Publisher : World Health Organization
Page : 65 pages
File Size : 41,6 Mb
Release : 2007
Category : Medical
ISBN : 9789241563437

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Promoting Safety of Medicines for Children by World Health Organization Pdf

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.

Fundamentals of Pediatric Drug Dosing

Iftekhar Mahmood,Gilbert Burckart
Fundamentals of Pediatric Drug Dosing Book PDF

Author : Iftekhar Mahmood,Gilbert Burckart
Publisher : Springer
Page : 146 pages
File Size : 55,7 Mb
Release : 2016-10-28
Category : Medical
ISBN : 9783319437545

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Fundamentals of Pediatric Drug Dosing by Iftekhar Mahmood,Gilbert Burckart Pdf

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.

Pediatric Formulations

Daniel Bar-Shalom,Klaus Rose
Pediatric Formulations Book PDF

Author : Daniel Bar-Shalom,Klaus Rose
Publisher : Springer Science & Business Media
Page : 429 pages
File Size : 51,6 Mb
Release : 2014-01-30
Category : Medical
ISBN : 9781489980113

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Pediatric Formulations by Daniel Bar-Shalom,Klaus Rose Pdf

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 Development and Rare Pediatric Diseases

Frederick Johnston
Drug Development and Rare Pediatric Diseases Book PDF

Author : Frederick Johnston
Publisher : Nova Biomedical Books
Page : 122 pages
File Size : 48,9 Mb
Release : 2021-08
Category : Medical
ISBN : 1536102288

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Drug Development and Rare Pediatric Diseases by Frederick Johnston Pdf

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.

Improving Medicines for Children in Canada

Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth
Improving Medicines for Children in Canada Book PDF

Author : Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth
Publisher : Unknown
Page : 128 pages
File Size : 51,9 Mb
Release : 2014
Category : Drugs
ISBN : 1926558863

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Improving Medicines for Children in Canada by Council of Canadian Academies. Expert Panel on Therapeutic Products for Infants, Children, and Youth Pdf

"Recognizing the importance of developing safe and effective medicines specifically for children, the Minister of Health, on behalf of Health Canada, asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment of the state of research and regulations leading to the approval of therapeutic products for children, in Canada and abroad. Specifically, this assessment examines the following questions: What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labelled as therapies for infants, children, and youth? How does human development from infancy to youth alter clinical pharmacology and therefore inform pediatric drug investigations? What are best practices to ethically conduct scientifically sound but adaptive drug studies to confirm the safety and effectiveness of drugs for infants, children, and youth? When the participation of infants, children, and youth in drug studies is not feasible, what are the best practices to confirm drug safety and effectiveness in these populations? What are Canada's strengths to contribute to global pharmacovigilance efforts for drugs that may benefit infants, children, and youth?"--Executive summary.

Ethical Conduct of Clinical Research Involving Children

Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Ethical Conduct of Clinical Research Involving Children Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 46,7 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

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.

Drug Safety Evaluation

Shayne Cox Gad
Drug Safety Evaluation Book PDF

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 918 pages
File Size : 47,7 Mb
Release : 2016-11-18
Category : Medical
ISBN : 9781119097402

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Drug Safety Evaluation by Shayne Cox Gad Pdf

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

Considering the Patient in Pediatric Drug Development

Klaus Rose
Considering the Patient in Pediatric Drug Development Book PDF

Author : Klaus Rose
Publisher : Academic Press
Page : 416 pages
File Size : 52,9 Mb
Release : 2020-11-19
Category : Business & Economics
ISBN : 9780128242056

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Considering the Patient in Pediatric Drug Development by Klaus Rose Pdf

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