Pediatric Drug Development

Pediatric Drug Development PDF 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.

Pediatric Drug Development

Pediatric Drug Development PDF Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782

Get Book Here

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

Safe and Effective Medicines for Children PDF 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.

Prescribing Medications for Children

Prescribing Medications for Children PDF Author: Neil Buchanan
Publisher: MacLennan & Petty
ISBN: 9780864330161
Category : Drugs
Languages : en
Pages : 140

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Book Description


Fast Facts Handbook for Pediatric Primary Care

Fast Facts Handbook for Pediatric Primary Care PDF Author: Kristine M Ruggiero, PhD, MSN, RN, CPNP
Publisher: Springer Publishing Company
ISBN: 0826151841
Category : Medical
Languages : en
Pages : 312

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Book Description
Uniquely written from the perspectives of a Nurse Practitioner and a Physician Assistant This quick-access reference guide encompasses all key diagnostic and management essentials needed for safe and effective pediatric practice. By incorporating the most current literature and evidence-based practice, this guide explains how to best assess, diagnose, and treat common pediatric disorders in an ambulatory care setting. This practical, pocket-sized resource is presented in concise paragraphs, providing access to key information at a glance. Chapters consistently include focused assessment and diagnosis of the most common clinical problems and treatment options. Key points, important developmental milestones, and illness prevention and management sections provide practitioners with important content to educate patients and families easily and thoroughly. Abundant tables and charts help to facilitate quick reference to key components of practice. Links to frequently updated clinical guidelines and important web resources ensure that practitioners can maintain access to the most current knowledge available. Key Features: Provides speedy access to crucial information with concise paragraphs, chapter objectives, key points, and tables Conveniently organized by most commonly seen diseases and disorders Provides links to frequently updated clinical guidelines and web resources Purchase includes digital access for use on most mobile devices or computers

Children's Prescription Drugs

Children's Prescription Drugs PDF Author:
Publisher:
ISBN: 9780785321637
Category : Medical
Languages : en
Pages : 408

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Book Description
This special guide profiles hundreds of the most commonly-prescribed brand name and generic medications for children, as well as commonly recommended over-the-counter preparations. Each profile includes common uses, side effects and interactions, and warnings for each drug.

Prescriber's Guide – Children and Adolescents

Prescriber's Guide – Children and Adolescents PDF Author: Stephen M. Stahl
Publisher: Cambridge University Press
ISBN: 1108446566
Category : Medical
Languages : en
Pages : 525

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Book Description
Presents a user-friendly step-by-step manual on the psychotropic drugs prescribed for children and adolescents by clinicians and nurse practitioners.

Prescribing Medicines for Children

Prescribing Medicines for Children PDF Author: Mike Sharland
Publisher:
ISBN: 9780857111357
Category : Chemotherapy
Languages : en
Pages : 0

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Book Description
Prescribing for children is a particularly challenging discipline due to specific issues of drug absorption, metabolism, distribution and excretion. The aim of this book is to improve understanding in all aspects of paediatric prescribing, from the development of suitable drugs through to their practical administration. With its origins in the EU-funded Global Research in Paediatrics (GRiP) project this is the first truly international textbook to provide guidance on the principles behind optimal neonatal and paediatric prescribing. Harnessing the international expertise of paediatricians and pharmacists in the field, Prescribing Medicines for Children compliments the British National Formulary for Children (BNFC), facilitating translation of essential pharmacological principles into good prescribing practice. It incorporates specific information on how to promote safe and effective prescribing in paediatrics, including how to avoid medication errors and adverse drug reactions in children. Highlights include the differences in prescribing habits between countries and the shared principles that underpin rational prescribing in paediatrics and neonatology. The book is divided into two sections: Section A provides concise educational material relating to paediatric pharmacology and optimising how medicines are developed and prescribed for children. Section B considers key clinical prescribing areas and can be used as a quick reference guide. Each chapter is focused on the key issues in prescribing for a respective clinical specialty or context. Prescribing Medicines for Children is essential reading for all those who are involved in prescribing medicines to neonates and children. This includes undergraduate and postgraduate pharmacists, nurses, paediatricians and primary care physicians, academic scientists, and those working in the pharmaceutical industry and drug regulation.

Straight Talk about Psychiatric Medications for Kids, Fourth Edition

Straight Talk about Psychiatric Medications for Kids, Fourth Edition PDF Author: Timothy E. Wilens
Publisher: Guilford Publications
ISBN: 1462519857
Category : Health & Fitness
Languages : en
Pages : 354

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Book Description
"When a child is struggling with an emotional or behavioral problem, parents face many difficult decisions. Is medication the right choice? What about side effects? How long will medication be needed? In this authoritative guide, leading child psychiatrists Drs. Timothy Wilens and Paul Hammerness explain the nuts and bolts of psychiatric medications--from how they work and potential risks to their impact on a child's emotions, school performance, personality, and health. Extensively revised to include the latest information about medications and their uses, the fourth edition is even more accessible, and includes pullouts, bulleted lists, and "take home points" highlighting critical facts. In addition to parents, this is an ideal reference for teachers and other school professionals"--

Medications in Pediatrics

Medications in Pediatrics PDF Author: American Academy of Pediatrics
Publisher:
ISBN: 9781610024341
Category :
Languages : en
Pages : 500

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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...

Promoting Safety of Medicines for Children

Promoting Safety of Medicines for Children PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241563435
Category : Medical
Languages : en
Pages : 65

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Book Description
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.