Pediatric Drug Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pediatric Drug Development write by Andrew E. Mulberg. This book was released on 2013-05-20. Pediatric Drug Development available in PDF, EPUB and Kindle. 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.
Safe and Effective Medicines for Children
Safe and Effective Medicines for Children - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Safe and Effective Medicines for Children write by Institute of Medicine. This book was released on 2012-10-13. Safe and Effective Medicines for Children available in PDF, EPUB and Kindle. 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.
Pediatric Drug Development
Pediatric Drug Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Pediatric Drug Development write by Andrew E. Mulberg. This book was released on 2011-09-20. Pediatric Drug Development available in PDF, EPUB and Kindle. 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.
Guide to Paediatric Drug Development and Clinical Research
Guide to Paediatric Drug Development and Clinical Research - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Guide to Paediatric Drug Development and Clinical Research write by Klaus Rose. This book was released on 2010-01-01. Guide to Paediatric Drug Development and Clinical Research available in PDF, EPUB and Kindle. 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.
Addressing the Barriers to Pediatric Drug Development
Addressing the Barriers to Pediatric Drug Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Addressing the Barriers to Pediatric Drug Development write by Institute of Medicine. This book was released on 2008-08-12. Addressing the Barriers to Pediatric Drug Development available in PDF, EPUB and Kindle. 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.
