Pediatric Drug Development

Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publisher : John Wiley & Sons
Page : 782 pages
File Size : 52,6 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.

Author : Jocelyn Jennings,Linda McBride
Publisher : Unknown
Page : 128 pages
File Size : 54,7 Mb
Release : 2021-11-26
Category : Electronic
ISBN : 1947493736

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Global Pediatric Development of Drugs, Biologics, and Medical Devices by Jocelyn Jennings,Linda McBride Pdf

Author : Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
Publisher : John Wiley & Sons
Page : 843 pages
File Size : 42,9 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.

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 : 49,9 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.

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 : 50,9 Mb
Release : 2008-09-12
Category : Medical
ISBN : 9780309107426

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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.

Author : Klaus Rose,John N. Van den Anker
Publisher : Karger Medical and Scientific Publishers
Page : 240 pages
File Size : 47,9 Mb
Release : 2010-01-01
Category : Medical
ISBN : 9783805593625

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Guide to Paediatric Drug Development and Clinical Research by Klaus Rose,John N. Van den Anker Pdf

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 : Institute of Medicine,Division of Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices,Jonathan R. Davis,Sarah Pitluck,Peter Bouxsein,Ronald W. Estabrook
Publisher : National Academies Press
Page : 135 pages
File Size : 48,5 Mb
Release : 2000-04-07
Category : Medical
ISBN : 9780309183642

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Rational Therapeutics for Infants and Children by Institute of Medicine,Division of Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices,Jonathan R. Davis,Sarah Pitluck,Peter Bouxsein,Ronald W. Estabrook Pdf

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 : Raymond A. Huml
Publisher : Springer Nature
Page : 418 pages
File Size : 40,9 Mb
Release : 2021-11-08
Category : Medical
ISBN : 9783030786052

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Rare Disease Drug Development by Raymond A. Huml Pdf

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 : Chris J. van Boxtel,Budiono Santoso,I. Ralph Edwards
Publisher : John Wiley & Sons
Page : 738 pages
File Size : 55,6 Mb
Release : 2001-11-28
Category : Medical
ISBN : 0471899275

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Drug Benefits and Risks by Chris J. van Boxtel,Budiono Santoso,I. Ralph Edwards Pdf

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 : Daniel Bar-Shalom,Klaus Rose
Publisher : Springer Science & Business Media
Page : 429 pages
File Size : 55,9 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.

Author : Iftekhar Mahmood,Gilbert Burckart
Publisher : Springer
Page : 146 pages
File Size : 47,7 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.

Author : Sumner J. Yaffe,Jacob V. Aranda
Publisher : Lippincott Williams & Wilkins
Page : 1072 pages
File Size : 49,6 Mb
Release : 2011
Category : Medical
ISBN : 9780781795388

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Neonatal and Pediatric Pharmacology by Sumner J. Yaffe,Jacob V. Aranda Pdf

"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 : Omboon Vallisuta,Suleiman Olimat
Publisher : BoD – Books on Demand
Page : 332 pages
File Size : 55,8 Mb
Release : 2015-06-03
Category : Medical
ISBN : 9789535121282

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Drug Discovery and Development by Omboon Vallisuta,Suleiman Olimat Pdf

It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against Infectious Diseases; Advanced Methodology.

Author : United States. Food and Drug Administration. Bureau of Drugs
Publisher : Unknown
Page : 20 pages
File Size : 52,5 Mb
Release : 1977
Category : Drugs
ISBN : UOM:39015003205054

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General Considerations for the Clinical Evaluation of Drugs by United States. Food and Drug Administration. Bureau of Drugs Pdf

Author : Hannsjörg W. Seyberth,Anders Rane,Matthias Schwab
Publisher : Springer Science & Business Media
Page : 385 pages
File Size : 49,5 Mb
Release : 2011-09-01
Category : Medical
ISBN : 9783642201950

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Pediatric Clinical Pharmacology by Hannsjörg W. Seyberth,Anders Rane,Matthias Schwab Pdf

The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy.