Considering the Patient in Pediatric Drug Development

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  • Publisher : Academic Press
  • Release : 19 November 2020
  • ISBN : 9780128242056
  • Page : 414 pages
  • Rating : 4.5/5 from 103 voters

Considering the Patient in Pediatric Drug Development Book PDF summary

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

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Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development
  • Author : Klaus Rose
  • Publisher : Academic Press
  • Release Date : 2020-11-19
  • ISBN : 9780128242056
DOWNLOAD 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,Steven A. Silber,John N. van den Anker
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • ISBN : 9781118210437
DOWNLOAD BOOKPediatric Drug Development

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 Date : 2012-10-13
  • ISBN : 9780309225496
DOWNLOAD 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

Pediatric Drug Development

Pediatric Drug Development
  • Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
  • Publisher : John Wiley & Sons
  • Release Date : 2013-05-20
  • ISBN : 9781118312056
DOWNLOAD 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.

Drug Discovery and Development

Drug Discovery and Development
  • Author : Vishwanath Gaitonde,Partha Karmakar,Ashit Trivedi
  • Publisher : BoD – Books on Demand
  • Release Date : 2020-03-11
  • ISBN : 9781789239751
DOWNLOAD 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

The COVID-19 Pandemic

The COVID-19 Pandemic
  • Author : Klaus Rose
  • Publisher : Academic Press
  • Release Date : 2022-03-14
  • ISBN : 9780323993876
DOWNLOAD BOOKThe 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

Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release Date : 2008-08-12
  • ISBN : 0309178657
DOWNLOAD BOOKAddressing the Barriers to Pediatric Drug Development

Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent--have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs

Drug Discovery and Development

Drug Discovery and Development
  • Author : Omboon Vallisuta,Suleiman Olimat
  • Publisher : BoD – Books on Demand
  • Release Date : 2015-06-03
  • ISBN : 9789535121282
DOWNLOAD 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

The Management of Clinical Trials

The Management of Clinical Trials
  • Author : Hesham Abdeldayem
  • Publisher : BoD – Books on Demand
  • Release Date : 2018-06-06
  • ISBN : 9781789232387
DOWNLOAD BOOKThe Management of Clinical Trials

This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.

Fundamentals of Pediatric Drug Dosing

Fundamentals of Pediatric Drug Dosing
  • Author : Iftekhar Mahmood,Gilbert Burckart
  • Publisher : Springer
  • Release Date : 2016-10-28
  • ISBN : 9783319437545
DOWNLOAD BOOKFundamentals 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 Date : 2019-09-15
  • ISBN : 9780081006177
DOWNLOAD BOOKClinical 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.

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 Date : 2012-10-18
  • ISBN : 9780123878168
DOWNLOAD 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

General Considerations for the Clinical Evaluation of Drugs

General Considerations for the Clinical Evaluation of Drugs
  • Author : United States. Food and Drug Administration. Bureau of Drugs,United States. Food and Drug Administration
  • Publisher : Unknown
  • Release Date : 1977
  • ISBN : MINN:31951003051226S
DOWNLOAD BOOKGeneral Considerations for the Clinical Evaluation of Drugs

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 Date : 2010-05-21
  • ISBN : 9783805593632
DOWNLOAD 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

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release Date : 2014-02-06
  • ISBN : 9780309292498
DOWNLOAD BOOKImproving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective