Considering the Patient in Pediatric Drug Development

Produk Detail:
  • Author : Klaus Rose
  • Publisher : Academic Press
  • Pages : 414 pages
  • ISBN : 0128242051
  • Rating : /5 from reviews
CLICK HERE TO GET THIS BOOK >>>Considering the Patient in Pediatric Drug Development

Download or Read online Considering the Patient in Pediatric Drug Development full in PDF, ePub and kindle. this book written by Klaus Rose and published by Academic Press which was released on 19 November 2020 with total page 414 pages. We cannot guarantee that Considering the Patient in Pediatric Drug Development book is available in the library, click Get Book button and read full online book in your kindle, tablet, IPAD, PC or mobile whenever and wherever You Like. 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

Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development
  • Author : Klaus Rose
  • Publisher : Academic Press
  • Release : 19 November 2020
GET THIS BOOK Considering the Patient in Pediatric Drug Development

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

Pediatric Drug Development

Pediatric Drug Development
  • Author : Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOK 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

Pediatric Drug Development

Pediatric Drug Development
  • Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
  • Publisher : John Wiley & Sons
  • Release : 20 May 2013
GET THIS BOOK Pediatric Drug Development

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.

The COVID 19 Pandemic

The COVID 19 Pandemic
  • Author : Klaus Rose
  • Publisher : Academic Press
  • Release : 14 March 2022
GET THIS BOOK The COVID 19 Pandemic

The COVID-19 Pandemic: A Global High-Tech Challenge at the Interface of Science, Politics, and Illusions discusses COVID-19 from a historical basis. Many of today’s key decisions are based on flawed assumptions and blind spots, including the belief that healthcare institutions, researchers and authorities are driven by patients’ interests, while industry is greedy. Examples include the US Operation Warp Speed to expedite the development of tools against the pandemic, the EU’s inability to establish a working relationship with vaccine

Pediatric Drug Development

Pediatric Drug Development
  • Author : Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
  • Publisher : Wiley-Blackwell
  • Release : 13 April 2009
GET THIS BOOK 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

Fundamentals of Pediatric Drug Dosing

Fundamentals of Pediatric Drug Dosing
  • Author : Iftekhar Mahmood,Gilbert Burckart
  • Publisher : Springer
  • Release : 28 October 2016
GET THIS BOOK Fundamentals of Pediatric Drug Dosing

Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children.

Clinical Research in Paediatric Psychopharmacology

Clinical Research in Paediatric Psychopharmacology
  • Author : Philippe Auby
  • Publisher : Woodhead Publishing
  • Release : 15 September 2019
GET THIS BOOK Clinical Research in Paediatric Psychopharmacology

Clinical Research in Paediatric Psychopharmacology: An Overview of the Ethical, Scientific and Regulatory Aspects provides a practical guide and overview of the ethical, scientific and regulatory aspects of clinical research in pediatric psychopharmacology, also discussing practical points to consider when developing clinical research in this field. The book is ideal for professionals involved in clinical research in pediatric psychopharmacology, i.e., including, but not limited to pediatricians, health care professionals, researchers, investigators, pharmaceutical company personals and potentially ethics committee members.

Pediatric Formulations

Pediatric Formulations
  • Author : Daniel Bar-Shalom,Klaus Rose
  • Publisher : Springer Science & Business Media
  • Release : 30 January 2014
GET THIS BOOK Pediatric Formulations

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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release : 18 October 2012
GET THIS BOOK A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules

Guide to Paediatric Drug Development and Clinical Research

Guide to Paediatric Drug Development and Clinical Research
  • Author : K. Rose,J.N. van den Anker
  • Publisher : Karger Medical and Scientific Publishers
  • Release : 21 May 2010
GET THIS BOOK 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

  • Author : Anonim
  • Publisher : Springer Nature
  • Release : 04 December 2022
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The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
  • Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
  • Publisher : Academic Press
  • Release : 13 March 2015
GET THIS BOOK The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity

Applications of Pharmacokinetic Principles in Drug Development

Applications of Pharmacokinetic Principles in Drug Development
  • Author : Rajesh Krishna
  • Publisher : Springer Science & Business Media
  • Release : 04 December 2022
GET THIS BOOK Applications of Pharmacokinetic Principles in Drug Development

This book presents a collection of articles that represent individual and expert perspectives in both preclinical and clinical development, including case studies on real-life examples of successful drugs that add value to the pharmacokinetic principles learned and applied. Unlike existing books that focus on pharmacokinetic theory, the current book emphasizes application of pharmacokinetic principles in new drug development.

Frontiers in Cardiovascular Drug Discovery Volume 4

Frontiers in Cardiovascular Drug Discovery  Volume 4
  • Author : Atta-ur-Rahman,M. Iqbal Choudhary
  • Publisher : Bentham Science Publishers
  • Release : 05 April 2019
GET THIS BOOK Frontiers in Cardiovascular Drug Discovery Volume 4

Frontiers in Cardiovascular Drug Discovery is an eBook series devoted to publishing the latest advances in cardiovascular drug design and discovery. Each volume brings reviews on the biochemistry, in-silico drug design, combinatorial chemistry, high-throughput screening, drug targets, recent important patents, and structure-activity relationships of molecules used in cardiovascular therapy. The eBook series should prove to be of great interest to all medicinal chemists and pharmaceutical scientists involved in preclinical and clinical research in cardiology. The fourth volume of the series

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition
  • Author : Allen Cato,Lynda Sutton,Allen Cato III
  • Publisher : CRC Press
  • Release : 26 March 2002
GET THIS BOOK Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or