Pediatric Drug Development


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.




Safe and Effective Medicines for Children


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.




Medications in Pediatrics


Book Description

This new compendium contains AAP clinical practice guidelines, policy statements, clinical reports, and technical reports related to the use of medications in the pediatric population. It is designed to be a handy reference to AAP policies and recommended best practices. Sections include Pediatric Drug Principles Allergy/Asthma Management Contraception Emergency Care Infections Mental Health Management Substance Use Issues Neonatal Care Pain Management Plus much more...




Pediatric Drug Formulations


Book Description




Pediatric Injectable Drugs


Book Description

For more than two decades, Pediatric Injectable Drugs (The Teddy Bear Book), has served an important and continuing need for reliable evidence-based information specific to pediatric injectable drugs. The tenth edition of this invaluable reference has grown to cover 238 drugs commonly used in the treatment of infants and children, including 20 new to this edition.




Children's Medicines


Book Description

An indispensable guide to children’s medications that belongs on the bookshelf of every parent, grandparent, and teacher. Most parents have worried about the side effects and possible long-term consequences of administering a particular medication to their child. The medication may be available over-the-counter, like cough syrup, or it may be prescribed by a doctor, like an antibiotic. Parents want to know: Is the medication safe? Is it effective? Will it help my child? A pediatric pharmacist for nearly thirty years, Edward A. Bell has spent his career listening carefully to parents' concerns. In Children's Medicines, Bell draws on the latest scientific information, coupled with his experience in hospital and clinic settings, as a university professor, and as a parent, to answer questions about whether, when, and what medications to give to infants, children, and teenagers. Bell touches on practical issues of medication administration and explores areas of particular concern for parents. Inside the book, readers will find • information to help parents weigh the benefits and risks of medicines • an explanation of why some adult medications are not safe for children • descriptions of medicine for treating fever and common illnesses • practical tips on measuring, flavoring, and administering medicines • directions for giving medicine in the mouth, the nose, the ear, and the eye • advice for keeping children of any age safe around medications • facts about vaccinations: how they work, which ones are recommended, and their safety • a guide to the FDA's approval process for use of medicines by children • information about drug pricing, expiration dates, and storing medicine at home • a chapter on ADHD and the treatment of adolescent depression that takes into account the long-term side effects of antidepressants • details about the use of herbal and complementary therapies, including probiotics and vitamins • a discussion of over-the-counter cough/cold products • information on which websites to use for accurate medical and drug information Full of information helpful to parents, grandparents, and others who provide care for children, Children's Medicines is a reliable and insightful guide to how drugs for children of all ages are prescribed and used.




Addressing the Barriers to Pediatric Drug Development


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.




Pediatric Medications


Book Description

PEDIATRIC MEDICATIONS provides all nurses who care for pediatric patients with the most up-to-date, accurate, and comprehensive drug information on the market. Approximately 400 drug monographs are featured, organized alphabetically for easy retrieval. This comprehensive reference includes drugs commonly administered to pediatric patients in all settings, including neonates, children, and adolescents.







A Parent's Guide to Children's Medicines


Book Description

In A Parent's Guide to Children's Medicines, an experienced pediatric pharmacist answers questions about how to give safe and effective medications to children. Whether medicine is used to treat asthma or ear infections, medicine is often necessary and can be life saving—yet many parents worry about side effects and possible long-term consequences. This book tells parents how drugs for children are prescribed and used, and how to give these medications to children for the best results. Inside:• information to help parents weigh the benefits and risks of medicines • descriptions of medicine for treating fever, infection, and common illnesses• practical tips on measuring, flavoring, and administering liquid medicines• directions for giving medicine in the mouth, the nose, the ear, and the eye • advice for keeping children safe around medications • facts about vaccinations: how do they work, and are they safe?• answers to parents’ frequently asked questions -- Phil Brunell, M.D., Professor of Pediatrics Emeritus, University of California, Los Angeles