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Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development
How Good Intentions Turned Into Harm

by Klaus Rose

  • Publisher : Academic Press
  • Release : 2020-11-19
  • Pages : 414
  • ISBN : 0128242051
  • Language : En, Es, Fr & De
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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

Pediatric Drug Development

Pediatric Drug Development
A Book

by Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis

  • Publisher : John Wiley & Sons
  • Release : 2013-05-20
  • Pages : 624
  • ISBN : 1118312058
  • Language : En, Es, Fr & De
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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.

Clinical Research in Paediatric Psychopharmacology

Clinical Research in Paediatric Psychopharmacology
A Practical Overview of the Ethical, Scientific, and Regulatory Aspects

by Philippe Auby

  • Publisher : Woodhead Publishing
  • Release : 2019-09-15
  • Pages : 218
  • ISBN : 0081006179
  • Language : En, Es, Fr & De
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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. Topics discussed include the role of patient organization and advocacy groups in research, the role of families and patients: ‘should I involve my kid in clinical research, and historical, ethical, regulatory, clinical, scientific, intercultural and practical aspects of clinical research in child and adolescent psychopharmacology. Covers both theoretical and practical aspects of clinical research in paediatric psychopharmacology Approaches the topic from different angles from the regulatory framework to the patient perspective Discusses ethical and safety considerations for research in paediatric psychopharmacology Offers future perspective for paediatric development

Fundamentals of Pediatric Drug Dosing

Fundamentals of Pediatric Drug Dosing
A Book

by Iftekhar Mahmood,Gilbert Burckart

  • Publisher : Springer
  • Release : 2016-10-28
  • Pages : 146
  • ISBN : 3319437542
  • Language : En, Es, Fr & De
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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. Children are not ‘small adults’, and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.

Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition
A Book

by Allen Cato,Lynda Sutton,Allen Cato III

  • Publisher : CRC Press
  • Release : 2002-03-26
  • Pages : 368
  • ISBN : 0824744802
  • Language : En, Es, Fr & De
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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 clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Clinical Trials

Clinical Trials
What Patients and Volunteers Need to Know

by Lorna Speid, Ph.D

  • Publisher : Oxford University Press
  • Release : 2010-07-30
  • Pages : 208
  • ISBN : 9780199752805
  • Language : En, Es, Fr & De
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Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.

The Journal of Clinical Pediatric Dentistry

The Journal of Clinical Pediatric Dentistry
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2007
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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The Emergency Medicine Reports Textbook of Adult and Pediatric Emergency Medicine

The Emergency Medicine Reports Textbook of Adult and Pediatric Emergency Medicine
Principles, Protocols, Pathways

by American Health Consultants

  • Publisher : Amer Health Consultant
  • Release : 2002
  • Pages : 1708
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Handbook of Non-prescription Drugs

Handbook of Non-prescription Drugs
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2004
  • Pages : 1370
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pain in Infants, Children, and Adolescents

Pain in Infants, Children, and Adolescents
A Book

by Neil L. Schechter,Charles B. Berde,Myron Yaster

  • Publisher : Lippincott Williams & Wilkins
  • Release : 1993
  • Pages : 691
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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This book provides children's health care professionals and other practitioners with the tools necessary to assess and manage pain in children. It centralizes information about children's pain, dispels myths about the child's experience of pain, provides a foundation for future research and attempts to change attitudes which foster undertreatment. This book offers a comprehensive analysis which addresses this complex and controversial topic from a multidisciplinary approach.

Workshop on Antiepileptic Drug Development

Workshop on Antiepileptic Drug Development
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1977
  • Pages : 73
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Behavioral Science in Pediatric Medicine

Behavioral Science in Pediatric Medicine
A Book

by Nathan Bill Talbot,Jerome Kagan,Leon Eisenberg

  • Publisher : W.B. Saunders Company
  • Release : 1971
  • Pages : 467
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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AHFS Drug Information

AHFS Drug Information
Essentials 2006-2007

by Gerald K. McEvoy

  • Publisher : Amer Soc of Health System
  • Release : 2006
  • Pages : 2265
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pediatric Dentistry

Pediatric Dentistry
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2000
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pediatric Pharmacology

Pediatric Pharmacology
Therapeutic Principles in Practice

by Sumner J. Yaffe

  • Publisher : W B Saunders Company
  • Release : 1992
  • Pages : 663
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Covers the general principles of pediatric pharmacology from a clinical perspective. Over 80 distinguished authorities discuss drugs and pregnancy, with special emphasis on maternal-fetal medicine, drugs and the infant, child, and adolescent, as well as specific drugs and adverse drug effects.

PAREXEL's Pharmaceutical R & D Statistical Sourcebook

PAREXEL's Pharmaceutical R & D Statistical Sourcebook
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2002
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Rationality of Drug Development

Rationality of Drug Development
Proceedings of the Second International Meeting of Medical Advisers in the Pharmaceutical Industry, Florence, October 13-15, 1975

by P. E. Lucchelli,N. Bergamini,V. Bachini

  • Publisher : Excerpta Medica
  • Release : 1976
  • Pages : 263
  • ISBN : 9780444152176
  • Language : En, Es, Fr & De
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End Stage Renal Disease in Children

End Stage Renal Disease in Children
A Book

by Richard N. Fine,Alan B. Gruskin

  • Publisher : W B Saunders Company
  • Release : 1984
  • Pages : 586
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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American Journal of Hospital Pharmacy

American Journal of Hospital Pharmacy
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1988-04
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pediatric Epilepsy

Pediatric Epilepsy
Diagnosis and Therapy

by W. Edwin Dodson,John M. Pellock

  • Publisher : Demos Medical Publishing
  • Release : 1993
  • Pages : 446
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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