Considering the Patient in Pediatric Drug Development

Considering the Patient in Pediatric Drug Development
Author: Klaus Rose
Publsiher: Academic Press
Total Pages: 414
Release: 2020-11-19
ISBN 10: 0128242051
ISBN 13: 9780128242056
Language: EN, FR, DE, ES & NL

Considering the Patient in Pediatric Drug Development Book Review:

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
Author: Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publsiher: John Wiley & Sons
Total Pages: 624
Release: 2013-05-20
ISBN 10: 1118312058
ISBN 13: 9781118312056
Language: EN, FR, DE, ES & NL

Pediatric Drug Development Book Review:

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.

Pediatric Drug Development

Pediatric Drug Development
Author: Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publsiher: John Wiley & Sons
Total Pages: 624
Release: 2013-05-20
ISBN 10: 1118312058
ISBN 13: 9781118312056
Language: EN, FR, DE, ES & NL

Pediatric Drug Development Book Review:

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: Omboon Vallisuta,Suleiman Olimat
Publsiher: BoD – Books on Demand
Total Pages: 330
Release: 2015-06-03
ISBN 10: 9535121286
ISBN 13: 9789535121282
Language: EN, FR, DE, ES & NL

Drug Discovery and Development Book Review:

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 Infectious Diseases; Advanced Methodology.

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
Publsiher: CRC Press
Total Pages: 368
Release: 2002-03-26
ISBN 10: 0824744802
ISBN 13: 9780824744809
Language: EN, FR, DE, ES & NL

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition Book Review:

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 Research in Paediatric Psychopharmacology

Clinical Research in Paediatric Psychopharmacology
Author: Philippe Auby
Publsiher: Woodhead Publishing
Total Pages: 218
Release: 2019-09-15
ISBN 10: 0081006179
ISBN 13: 9780081006177
Language: EN, FR, DE, ES & NL

Clinical Research in Paediatric Psychopharmacology Book Review:

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

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)
Publsiher: National Academies Press
Total Pages: 432
Release: 2012-10-13
ISBN 10: 0309225493
ISBN 13: 9780309225496
Language: EN, FR, DE, ES & NL

Safe and Effective Medicines for Children Book Review:

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 policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Fundamentals of Pediatric Drug Dosing

Fundamentals of Pediatric Drug Dosing
Author: Iftekhar Mahmood,Gilbert Burckart
Publsiher: Springer
Total Pages: 146
Release: 2016-10-28
ISBN 10: 3319437542
ISBN 13: 9783319437545
Language: EN, FR, DE, ES & NL

Fundamentals of Pediatric Drug Dosing Book Review:

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.

The Management of Clinical Trials

The Management of Clinical Trials
Author: Hesham Abdeldayem
Publsiher: BoD – Books on Demand
Total Pages: 90
Release: 2018-06-06
ISBN 10: 1789232384
ISBN 13: 9781789232387
Language: EN, FR, DE, ES & NL

The Management of Clinical Trials Book Review:

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.

Clinical Trials

Clinical Trials
Author: Lorna Speid, Ph.D
Publsiher: Oxford University Press
Total Pages: 208
Release: 2010-07-30
ISBN 10: 9780199752805
ISBN 13: 019975280X
Language: EN, FR, DE, ES & NL

Clinical Trials Book Review:

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.

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publsiher: National Academies Press
Total Pages: 445
Release: 2004-07-09
ISBN 10: 9780309133388
ISBN 13: 0309133386
Language: EN, FR, DE, ES & NL

Ethical Conduct of Clinical Research Involving Children Book Review:

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation
Author: Institute of Medicine,Committee on Technological Innovation in Medicine
Publsiher: National Academies Press
Total Pages: 244
Release: 1990-02-01
ISBN 10: 0309042860
ISBN 13: 9780309042864
Language: EN, FR, DE, ES & NL

Modern Methods of Clinical Investigation Book Review:

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Precision Medicine for Investigators Practitioners and Providers

Precision Medicine for Investigators  Practitioners and Providers
Author: Joel Faintuch,Salomao Faintuch
Publsiher: Academic Press
Total Pages: 640
Release: 2019-11-16
ISBN 10: 0128191791
ISBN 13: 9780128191798
Language: EN, FR, DE, ES & NL

Precision Medicine for Investigators Practitioners and Providers Book Review:

Precision Medicine for Investigators, Practitioners and Providers addresses the needs of investigators by covering the topic as an umbrella concept, from new drug trials to wearable diagnostic devices, and from pediatrics to psychiatry in a manner that is up-to-date and authoritative. Sections include broad coverage of concerning disease groups and ancillary information about techniques, resources and consequences. Moreover, each chapter follows a structured blueprint, so that multiple, essential items are not overlooked. Instead of simply concentrating on a limited number of extensive and pedantic coverages, scholarly diagrams are also included. Provides a three-pronged approach to precision medicine that is focused on investigators, practitioners and healthcare providers Covers disease groups and ancillary information about techniques, resources and consequences Follows a structured blueprint, ensuring essential chapters items are not overlooked

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publsiher: National Academies Press
Total Pages: 442
Release: 2011-04-03
ISBN 10: 0309158060
ISBN 13: 9780309158060
Language: EN, FR, DE, ES & NL

Rare Diseases and Orphan Products Book Review:

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Prescribing Medicines for Children

Prescribing Medicines for Children
Author: Mike Sharland
Publsiher: Unknown
Total Pages: 650
Release: 2019-02
ISBN 10: 9780857111357
ISBN 13: 0857111353
Language: EN, FR, DE, ES & NL

Prescribing Medicines for Children Book Review:

Prescribing for children is a particularly challenging discipline due to specific issues of drug absorption, metabolism, distribution and excretion. The aim of this book is to improve understanding in all aspects of paediatric prescribing, from the development of suitable drugs through to their practical administration. With its origins in the EU-funded Global Research in Paediatrics (GRiP) project this is the first truly international textbook to provide guidance on the principles behind optimal neonatal and paediatric prescribing. Harnessing the international expertise of paediatricians and pharmacists in the field, Prescribing Medicines for Children compliments the British National Formulary for Children (BNFC), facilitating translation of essential pharmacological principles into good prescribing practice. It incorporates specific information on how to promote safe and effective prescribing in paediatrics, including how to avoid medication errors and adverse drug reactions in children. Highlights include the differences in prescribing habits between countries and the shared principles that underpin rational prescribing in paediatrics and neonatology. The book is divided into two sections: Section A provides concise educational material relating to paediatric pharmacology and optimising how medicines are developed and prescribed for children. Section B considers key clinical prescribing areas and can be used as a quick reference guide. Each chapter is focused on the key issues in prescribing for a respective clinical specialty or context. Prescribing Medicines for Children is essential reading for all those who are involved in prescribing medicines to neonates and children. This includes undergraduate and postgraduate pharmacists, nurses, paediatricians and primary care physicians, academic scientists, and those working in the pharmaceutical industry and drug regulation.

Integrating Clinical Research into Epidemic Response

Integrating Clinical Research into Epidemic Response
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Global Health,Committee on Clinical Trials During the 2014-2015 Ebola Outbreak
Publsiher: National Academies Press
Total Pages: 342
Release: 2017-07-26
ISBN 10: 0309457769
ISBN 13: 9780309457767
Language: EN, FR, DE, ES & NL

Integrating Clinical Research into Epidemic Response Book Review:

The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

Pediatric Rehabilitation

Pediatric Rehabilitation
Author: Michael A. Alexander, MD,Dennis J. Matthews, MD
Publsiher: Demos Medical Publishing
Total Pages: 260
Release: 2009-09-18
ISBN 10: 1935281658
ISBN 13: 9781935281658
Language: EN, FR, DE, ES & NL

Pediatric Rehabilitation Book Review:

A Doody's Core Title 2012 Thoroughly updated and expanded, the new edition of the classic comprehensive reference on pediatric rehabilitation brings together specialists from the various wings of the pediatric rehabilitation community. This market-leading text covers everything from basic examination and psychological assessment to electrodiagnosis, therapeutic exercise, orthotics and assistive devices, and in-depth clinical management of the full range of childhood disabilities and injuries. Features include: Expanded new edition of Dr. Gabriella Molnars pioneering pediatric rehabilitation text Comprehensive coverage of all areas, with up-to-date information on therapy, exercise physiology, CAM, cancer, obesity, and joint replacement Clinical emphasis throughout Multi-specialty expert authorship

Protecting Children In Substance abusing Families

Protecting Children In Substance abusing Families
Author: Vickie Kropenske,Judy Howard
Publsiher: DIANE Publishing
Total Pages: 128
Release: 1995-06
ISBN 10: 9780788118265
ISBN 13: 0788118269
Language: EN, FR, DE, ES & NL

Protecting Children In Substance abusing Families Book Review:

Designed for professionals in the fields of child welfare, mental health, health care, education, law, the faith community & substance abuse prevention & treatment. Intended to help identify the various forms of parental substance abuse. Includes a section addressing the identification of substance-abusing clients. Reviews the characteristics of substance-abusing parents.Glossary. Bibliography. Charts & tables.

Cardiotoxicity

Cardiotoxicity
Author: Wenyong Tan
Publsiher: BoD – Books on Demand
Total Pages: 162
Release: 2018-11-14
ISBN 10: 1789842379
ISBN 13: 9781789842371
Language: EN, FR, DE, ES & NL

Cardiotoxicity Book Review:

Cardiotoxicity may be caused by radiotherapy and/or anticancer agents for many malignancies, adverse effects of some drugs in the context of medical intervention or heavy metal intake, especially during the anticancer therapy. This book intends to bring forward the recent development in toxicities from cancer treatment. It updates the possible mechanisms of cardiotoxicities of some anticancer agents and the suggested prevention and treatment strategies. This book contains many valuable contributions from the researchers in oncology and cardiology as well as the clinicians who are experts in this field.

Pediatric Nursing Psychiatric and Surgical Issues

Pediatric Nursing  Psychiatric and Surgical Issues
Author: Öner Özdemir
Publsiher: BoD – Books on Demand
Total Pages: 176
Release: 2015-02-04
ISBN 10: 9535117408
ISBN 13: 9789535117407
Language: EN, FR, DE, ES & NL

Pediatric Nursing Psychiatric and Surgical Issues Book Review:

The book is not a classic pediatric text book. It shows different approaches to some pediatric topics. Our aim in this book, as understood from its title, is to describe some specific issues related to nursing, psychiatric and surgical issues. The book Pediatric Nursing, Psychiatric and Surgical Issues has 8 chapters which are placed in 4 different sections, to enlighten patients and pediatricians on current developments on specific pediatric issues.