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Guide to Paediatric Clinical Research
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-,...
Neonatal and Pediatric Clinical Pharmacology, An Issue of Pediatric Clinics
The need for safe and effective use of medicines in children and WHO's initiative "Make Medicines Child Size" have boosted research and educational activities in the area of pediatric clinical drug research. This issue focuses on both general and specific aspects of neonatal and pediatric clinical pharmacology including ethics, pharmacogenomics, metabolomics, adverse drug reactions, pain medication, pulmonary hypertension and several other hot topics. The editors have been able to find outstanding authors for the different parts on neonatal and pediatric pharmacology.
Rickham's Neonatal Surgery
This book provides a detailed guide to neonatal surgery and its related disciplines including: fetal medicine, fetal surgery, radiology, newborn anaesthesia, intensive care, neonatal medicine, medical genetics, pathology, cardiac surgery, and urology. The book aims to cover all the latest advances in newborn surgery, with contributions from the basic sciences and laboratory research to reflect the steady progress in our current working knowledge and understanding of many neonatal surgical disorders. As huge advances have been made in neonatal surgery in the past decades, ethical issues, long term outcomes, and quality of life are also emphasised. This book is an authoritative reference for surgical residents in training, consultant surgeons, general surgeons with an interest in paediatric surgery, neonatologists, paediatricians, intensive care specialists, and nursing staff.
Guide to Paediatric Drug Development and Clinical Research
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 un...
Pediatric Drug Development
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.
Neonatal Pain
This completely revised and updated edition offers a comprehensive overview of neonatal pain assessment and treatment. It includes the field of fetal surgery, and many other topics have been updated or added, such as circumcision analgesia, new drugs, new insights into neurophysiologic pathways of neonatal pain and new drawbacks of analgesic drugs. While in the early years of the 21st century pain treatment in neonates was still optional, it is now a tenet, and more and more institutions are looking for inspiration and good references to create their own guidelines. Written by leading researchers in the field, this book provides that inspiration and offers a valuable tool for neonatologists, anesthetists, nurses and physiotherapists. Since it also deals with prenatal and postnatal surgery, it also appeals to surgeons.
Paediatric Clinical Pharmacology
The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals effectively treat children with the most appropriate medicine with minimal side effects.
Neonatal and Pediatric Pharmacology
"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, ge...
Pain in Neonates and Infants
A new edition of a highly regarded text in the series on Pain Research and Clinical Management. The book is now used as a standard reference text for those working in the field of neonatology and paediatric pain assessment and management. It provides a comprehensive resource of the latest information in the field for use by both researchers and clinicians. The text is intended for use by all professionals working in the field: neonatologists; pediatricians; anestheiologists; nurses; psychologists. Multidisciplinary editorship and authorship ensuring relevancy and balance of content for all professional groups concerned. Clinically relevant and research based. Edited and written by the best k...
The Law of Off-label Uses of Medicines
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarif...
