Safety Efforts in Pediatric Drug Development PDF Download
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Author: Conor D. Byrne
Publisher:
ISBN: 9781607415657
Category : Child
Languages : en
Pages : 0
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Book Description
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.
Author: Conor D. Byrne
Publisher:
ISBN: 9781607415657
Category : Child
Languages : en
Pages : 0
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Book Description
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.
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: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782
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Book Description
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.
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118210433
Category : Medical
Languages : en
Pages : 843
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Book Description
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.
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: Iftekhar Mahmood
Publisher: Springer
ISBN: 3319437542
Category : Medical
Languages : en
Pages : 149
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Book Description
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.
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 160
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Book Description
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: 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: Barbara A. Reich
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. The safe and effective use of prescription drugs in children depends on a thorough understanding of the physiologic differences between children and adults. Currently, only one-third of drugs prescribed to children have been studied for safety and efficacy in pediatric populations. Until relatively recently, the Food and Drug Administration (FDA) made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Recent agency efforts to encourage pediatric drug research have generated mixed results and created unintended consequences. The development, prescribing, and safety evaluation of prescription drugs for children will require that the FDA and health care providers examine current practices, acknowledge their shortcomings, and consider creative solutions to the challenges associated with gathering additional data through pediatric drug research.
