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,Steven A. Silber,John N. van den Anker
Publsiher: John Wiley & Sons
Total Pages: 704
Release: 2011-09-20
ISBN 10: 1118210433
ISBN 13: 9781118210437
Language: EN, FR, DE, ES & NL

Pediatric Drug Development Book Review:

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.

Drug Discovery and Development

Drug Discovery and Development
Author: Vishwanath Gaitonde,Partha Karmakar,Ashit Trivedi
Publsiher: BoD – Books on Demand
Total Pages: 164
Release: 2020-03-11
ISBN 10: 1789239753
ISBN 13: 9781789239751
Language: EN, FR, DE, ES & NL

Drug Discovery and Development Book Review:

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 special topics describing target deorphaning in Mycobacterium tuberculosis, therapy treatment of some rare diseases, and developments in the pediatric drug discovery process.

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.

Chapter 35 The Importance of Geographic Differences in Pediatric Clinical Trials

Chapter 35  The Importance of Geographic Differences in Pediatric Clinical Trials
Author: Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
Publsiher: Wiley-Blackwell
Total Pages: 683
Release: 2009-08-13
ISBN 10: 9780470582398
ISBN 13: 0470582391
Language: EN, FR, DE, ES & NL

Chapter 35 The Importance of Geographic Differences in Pediatric Clinical Trials Book Review:

The first comprehensive treatmentof this vital topicFor decades, the specific needs of infants, children, and adolescents have been largely ignored in the drug development process, and healthcare providers have most often had to make do with pediatric dosing of drugs that were developed and intended for adults. Now, an awareness of the differences between the pediatric patient and the adult patient have begun to be realized and addressed by the pharmaceutical and wider healthcare industries, as well as the governmental and regulatory bodies that sanction the development and testing of drugs for children.This is the first book to provide a comprehensive treatment of pediatric drug development. Written by a team of experts, it provides industry, academia, and governmental agencies with an understanding of how to properly develop drugs for children without compromising business objectives. The authors address the scientific differences between the pediatric and adult subject in the development of pharmaceutical products. They discuss and consider: ethics--from product concept to production; specific medical needs of children; business rationale for the proper development of drugs for children; and the technical feasibility of studies and processes that are necessary for a proper pediatric drug development program.The book clearly explains the challenges and opportunities facing the entire healthcare community as it strives to improve the health of children worldwide. It demonstrates how these approaches will benefit all stakeholders and, ultimately, provide better and safer drugs for the pediatric population at large.This timely new work is essential reading for academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in pediatric drug development. It also serves as an important textbook for students in pharmacy, science, and medicine courses.

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
Publsiher: National Academies Press
Total Pages: 64
Release: 2008-08-12
ISBN 10: 9780309178655
ISBN 13: 0309178657
Language: EN, FR, DE, ES & NL

Addressing the Barriers to Pediatric Drug Development Book Review:

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 appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

The COVID 19 Pandemic

The COVID 19 Pandemic
Author: Klaus Rose
Publsiher: Academic Press
Total Pages: 248
Release: 2022-03-14
ISBN 10: 0323993877
ISBN 13: 9780323993876
Language: EN, FR, DE, ES & NL

The COVID 19 Pandemic Book Review:

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 developers, and the success stories of countries such as Israel and Taiwan. This book offers scientists and interested persons orientation and helps to decipher statements from governments and authorities. It will help professionals involved in the approval, planning, implementation and evaluation of COVID-19 studies to distinguish meaningful from pointless. Analyzes key features of the pandemic on the historical background of mankind’s development from hunters and gatherers to modern civilization Opens eyes to the self-interests of institutions and professional associations and resulting conflicts of interest Helps healthcare professionals address critical questions

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.

Chapter 31 Recruitment and Retention in Pediatric Clinical Trials

Chapter 31  Recruitment and Retention in Pediatric Clinical Trials
Author: Andrew E. Mulberg,John N. van den Anker,Steven A. Silber
Publsiher: Wiley-Blackwell
Total Pages: 684
Release: 2009-07-30
ISBN 10: 9780470582381
ISBN 13: 0470582383
Language: EN, FR, DE, ES & NL

Chapter 31 Recruitment and Retention in Pediatric Clinical Trials Book Review:

The first comprehensive treatmentof this vital topic For decades, the specific needs of infants, children, and adolescents have been largely ignored in the drug development process, and healthcare providers have most often had to make do with "pediatric dosing" of drugs that were developed and intended for adults. Now, an awareness of the differences between the pediatric patient and the adult patient have begun to be realized and addressed by the pharmaceutical and wider healthcare industries, as well as the governmental and regulatory bodies that sanction the development and testing of drugs for children. This is the first book to provide a comprehensive treatment of pediatric drug development. Written by a team of experts, it provides industry, academia, and governmental agencies with an understanding of how to properly develop drugs for children without compromising business objectives. The authors address the scientific differences between the pediatric and adult subject in the development of pharmaceutical products. They discuss and consider: ethics--from product concept to production; specific medical needs of children; business rationale for the proper development of drugs for children; and the technical feasibility of studies and processes that are necessary for a proper pediatric drug development program. The book clearly explains the challenges and opportunities facing the entire healthcare community as it strives to improve the health of children worldwide. It demonstrates how these approaches will benefit all stakeholders and, ultimately, provide better and safer drugs for the pediatric population at large. This timely new work is essential reading for academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in pediatric drug development. It also serves as an important textbook for students in pharmacy, science, and medicine courses.

Pediatric Formulations

Pediatric Formulations
Author: Daniel Bar-Shalom,Klaus Rose
Publsiher: Springer Science & Business Media
Total Pages: 439
Release: 2014-01-30
ISBN 10: 1489980113
ISBN 13: 9781489980113
Language: EN, FR, DE, ES & NL

Pediatric Formulations Book Review:

Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

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.

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
Publsiher: National Academies Press
Total Pages: 118
Release: 2014-02-06
ISBN 10: 0309292492
ISBN 13: 9780309292498
Language: EN, FR, DE, ES & NL

Improving and Accelerating Therapeutic Development for Nervous System Disorders Book Review:

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 and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

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

The Management of Clinical Trials

The Management of Clinical Trials
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2018
ISBN 10: 9781789232394
ISBN 13: 1789232392
Language: EN, FR, DE, ES & NL

The Management of Clinical Trials Book Review:

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author: Ali S. Faqi
Publsiher: Academic Press
Total Pages: 1024
Release: 2012-10-18
ISBN 10: 0123878160
ISBN 13: 9780123878168
Language: EN, FR, DE, ES & NL

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book Review:

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 and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

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.

Guide to Paediatric Drug Development and Clinical Research

Guide to Paediatric Drug Development and Clinical Research
Author: K. Rose,J.N. van den Anker
Publsiher: Karger Medical and Scientific Publishers
Total Pages: 242
Release: 2010-05-21
ISBN 10: 3805593635
ISBN 13: 9783805593632
Language: EN, FR, DE, ES & NL

Guide to Paediatric Drug Development and Clinical Research Book Review:

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 campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.

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.

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
Publsiher: Academic Press
Total Pages: 716
Release: 2015-03-13
ISBN 10: 012417146X
ISBN 13: 9780124171466
Language: EN, FR, DE, ES & NL

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book Review:

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 testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes