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 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

Produk Detail:

  • Author : Klaus Rose
  • Publisher : Academic Press
  • Pages : 414 pages
  • ISBN : 0128242051
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKConsidering the Patient in Pediatric Drug Development

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 BOOKConsidering 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,Dianne Murphy,Julia Dunne,Lisa L. Mathis
  • Publisher : John Wiley & Sons
  • Release : 20 May 2013
GET THIS BOOKPediatric 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 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 BOOKThe 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

Drug Discovery and Development

Drug Discovery and Development
  • Author : Vishwanath Gaitonde,Partha Karmakar,Ashit Trivedi
  • Publisher : BoD – Books on Demand
  • Release : 11 March 2020
GET THIS BOOKDrug Discovery and Development

The process of drug discovery and development is a complex multistage logistics project spanned over 10-15 years with an average budget exceeding 1 billion USD. Starting with target identification and synthesizing anywhere between 10k to 15k synthetic compounds to potentially obtain the final drug that reaches the market involves a complicated maze with multiple inter- and intra-operative fields. Topics described in this book emphasize the progresses in computational applications, pharmacokinetics advances, and molecular modeling developments. In addition the book also contains

Drug Discovery and Development

Drug Discovery and Development
  • Author : Omboon Vallisuta,Suleiman Olimat
  • Publisher : BoD – Books on Demand
  • Release : 03 June 2015
GET THIS BOOKDrug Discovery and Development

It is very important for scientists all over the globe to enhance drug discovery research for better human health. This book demonstrates that various expertise are essential for drug discovery including synthetic or natural drugs, clinical pharmacology, receptor identification, drug metabolism, pharmacodynamic and pharmacokinetic research. The following 5 sections cover diverse chapter topics in drug discovery: Natural Products as Sources of Leading Molecules in Drug Discovery; Oncology and Drug Discovery; Receptors Involvement in Drug Discovery; Management and Development of Drugs against

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 BOOKGuide 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

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 BOOKA 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

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
  • Publisher : National Academies Press
  • Release : 13 October 2012
GET THIS BOOKSafe and Effective Medicines for Children

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

Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society
  • Author : Sven Stegemann
  • Publisher : Springer
  • Release : 20 October 2016
GET THIS BOOKDeveloping Drug Products in an Aging Society

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
  • Author : Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
  • Publisher : CRC Press
  • Release : 23 December 2020
GET THIS BOOKCurrent Topics in Nonclinical Drug Development

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data.

Dermatological Drug Development

Dermatological Drug Development
  • Author : Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst
  • Publisher : Cambridge Scholars Publishing
  • Release : 18 September 2020
GET THIS BOOKDermatological Drug Development

This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and

Drug Therapy in Nursing

Drug Therapy in Nursing
  • Author : Diane S. Aschenbrenner,Samantha J. Venable
  • Publisher : Lippincott Williams & Wilkins
  • Release : 26 May 2022
GET THIS BOOKDrug Therapy in Nursing

This text presents a totally nursing-focused framework for teaching and learning nursing pharmacology, and "places the patient" at the center of all drug administration decisions and considerations. The book presents core drug knowledge using prototypes of different drug classes and emphasizes core patient variables that influence the patient's response to therapy. This thoroughly updated Third Edition covers newly approved drugs, has separate chapters on drugs affecting fungal and viral infections, and includes more pathophysiology information. FDA Black Box warnings have

Nelson Textbook of Pediatrics, 2-Volume Set

Nelson Textbook of Pediatrics, 2-Volume Set
  • Author : Robert M. Kliegman, MD,Bonita M.D. Stanton, MD,Joseph St. Geme, MD,Nina F Schor, MD, PhD
  • Publisher : Elsevier Health Sciences
  • Release : 22 April 2015
GET THIS BOOKNelson Textbook of Pediatrics, 2-Volume Set

After more than 75 years, Nelson Textbook of Pediatrics remains your indispensable source for definitive, state-of-the-art answers on every aspect of pediatric care. Embracing the new advances in science as well as the time-honored art of pediatric practice, this classic reference provides the essential information that practitioners and other care providers involved in pediatric health care throughout the world need to understand to effectively address the enormous range of biologic, psychologic, and social problems that our children and youth may face.

Supply Chain Management in the Drug Industry

Supply Chain Management in the Drug Industry
  • Author : Hedley Rees
  • Publisher : John Wiley & Sons
  • Release : 06 April 2011
GET THIS BOOKSupply Chain Management in the Drug Industry

This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until