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Considering The Patient In Pediatric Drug Development

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Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development Book
Author : Klaus Rose
Publisher : Academic Press
Release : 2020-11-19
ISBN : 0128242051
Language : En, Es, Fr & De

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Book 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

Pediatric Drug Development

Pediatric Drug Development Book
Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publisher : John Wiley & Sons
Release : 2013-05-20
ISBN : 1118312058
Language : En, Es, Fr & De

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Book 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.

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Release : 2002-03-26
ISBN : 0824744802
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Lorna Speid, Ph.D
Publisher : Oxford University Press
Release : 2010-07-30
ISBN : 9780199752805
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Anonim
Publisher : Unknown
Release : 2007
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Journal of Clinical Pediatric Dentistry book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Handbook of Non prescription Drugs

Handbook of Non prescription Drugs Book
Author : Anonim
Publisher : Unknown
Release : 2004
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Handbook of Non prescription Drugs book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pain in Infants Children and Adolescents

Pain in Infants  Children  and Adolescents Book
Author : Neil L. Schechter,Charles B. Berde,Myron Yaster
Publisher : Lippincott Williams & Wilkins
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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.

Behavioral Science in Pediatric Medicine

Behavioral Science in Pediatric Medicine Book
Author : Nathan Bill Talbot,Jerome Kagan,Leon Eisenberg
Publisher : W.B. Saunders Company
Release : 1971
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Behavioral Science in Pediatric Medicine book written by Nathan Bill Talbot,Jerome Kagan,Leon Eisenberg, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

AHFS Drug Information

AHFS Drug Information Book
Author : Gerald K. McEvoy
Publisher : Amer Soc of Health System
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download AHFS Drug Information book written by Gerald K. McEvoy, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pediatric Dentistry

Pediatric Dentistry Book
Author : Anonim
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Pediatric Dentistry book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pediatric Pharmacology

Pediatric Pharmacology Book
Author : Sumner J. Yaffe
Publisher : W B Saunders Company
Release : 1992
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Anonim
Publisher : Unknown
Release : 2002
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download PAREXEL s Pharmaceutical R D Statistical Sourcebook book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Rationality of Drug Development

Rationality of Drug Development Book
Author : P. E. Lucchelli,N. Bergamini,V. Bachini
Publisher : Excerpta Medica
Release : 1976
ISBN : 9780444152176
Language : En, Es, Fr & De

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Book Description :

Download Rationality of Drug Development book written by P. E. Lucchelli,N. Bergamini,V. Bachini, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

End Stage Renal Disease in Children

End Stage Renal Disease in Children Book
Author : Richard N. Fine,Alan B. Gruskin
Publisher : W B Saunders Company
Release : 1984
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download End Stage Renal Disease in Children book written by Richard N. Fine,Alan B. Gruskin, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

American Journal of Hospital Pharmacy

American Journal of Hospital Pharmacy Book
Author : Anonim
Publisher : Unknown
Release : 1988-04
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download American Journal of Hospital Pharmacy book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pediatric Epilepsy

Pediatric Epilepsy Book
Author : W. Edwin Dodson,John M. Pellock
Publisher : Demos Medical Publishing
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Pediatric Epilepsy book written by W. Edwin Dodson,John M. Pellock, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Burger s Medicinal Chemistry and Drug Discovery Therapeutic agents

Burger s Medicinal Chemistry and Drug Discovery  Therapeutic agents Book
Author : Alfred Burger
Publisher : Unknown
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Burger s Medicinal Chemistry and Drug Discovery Therapeutic agents book written by Alfred Burger, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Emergency Medicine

Emergency Medicine Book
Author : Anonim
Publisher : Unknown
Release : 2006
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Emergency Medicine book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

An Examination of Pediatric Drug Testing

An Examination of Pediatric Drug Testing Book
Author : Victoria J. Isada
Publisher : Unknown
Release : 2003
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download An Examination of Pediatric Drug Testing book written by Victoria J. Isada, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Problems in Pediatric Drug Therapy

Problems in Pediatric Drug Therapy Book
Author : Louis A. Pagliaro,Ann M. Pagliaro
Publisher : American Pharmaceutical Association
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This reference volume addresses distinct pharmaceutical care issues for all paediatric age ranges, from neonatal to adolescent. This third edition of the text includes two new chapters covering: paediatric pharmocokinetics and abusable psychtropic drugs.