Pediatric Clinical Pharmacology (Handbook of Experimental Pharmacology, 205)

Author by : Hannsjörg W. Seyberth
Languange Used : en
Release Date : 2011-09-01
Publisher by : Springer Science & Business Media

ISBN :

Description : 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....

Author by : Klaus Rose
Languange Used : en
Release Date : 2020-11-19
Publisher by : Academic Press

ISBN :

Description : Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information...

Author by : Daniel Bar-Shalom
Languange Used : en
Release Date : 2014-01-30
Publisher by : Springer Science & Business Media

ISBN :

Description : 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 by : Andrew E. Mulberg
Languange Used : en
Release Date : 2013-05-20
Publisher by : John Wiley & Sons

ISBN :

Description : Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development....

Author by : Esther Bui
Languange Used : en
Release Date : 2014-07-31
Publisher by : Cambridge University Press

ISBN :

Description : There are unique challenges to the care of women with epilepsy, including the gender-specific influences that women may experience owing to their age, hormonal status, and co-morbidities. Pregnancy is also a very important time for many women with epilepsy. This textbook is a portable, essential guide to the practical management of women with epilepsy. Busy clinicians can access a wealth of information summarized in a succinct and easily accessible format. Experts from around the world have reviewed and synthesized the available data from studies in hormones in epilepsy, pregnancy registries, and many aspects of the care of women with epilepsy from adolescence, through pregnancy, to menopause. Of interest to all who care for women with epilepsy, including neurologists, internists, obstetricians, anesthetists, primary care practitioners, nurses, and lactation consultants....

Author by : Wieland Kiess
Languange Used : en
Release Date : 2020-07-15
Publisher by : Springer Nature

ISBN :

Description : This volume provides readers with the most updated scientific information on the efficacy and safety of medicines for children and adolescents. The book enriches the understanding of pediatric pharmacotherapy for health professionals, regulatory agencies, pharmaceutical companies and learned societies. It contains important information on the pharmacodynamics and pharmacokinetics of drugs. It summarizes the latest investigations on the effects of pharmacological treatments in relation to and dependent on age, gender, fat mass and disease status. Therefore and importantly, this volume reviews the latest data on how pharmacotherapy has to be adjusted and personalized in regards to stages of development and during the pediatric lifespan from neonate through adolescence. In addition, the topic of rare diseases and special challenges for pharmacotherapy will be included and will provide readers with the necessary knowledge to handle complex diseases and treatment strategies especially in relation to pharmacotherapy of rare and orphan diseases....

Author by : Jo Madeleine Wilmshurst
Languange Used : en
Release Date : 2021-08-31
Publisher by : Frontiers Media SA

ISBN :

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