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: 0128242051
Category: Business & Economics
Language: EN, FR, DE, ES & NL

Considering the Patient in Pediatric Drug Development Book Excerpt:

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: 932
Release: 2011-09-20
ISBN: 1118210433
Category: Medical
Language: EN, FR, DE, ES & NL

Pediatric Drug Development Book Excerpt:

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

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: 1118312058
Category: Medical
Language: EN, FR, DE, ES & NL

Pediatric Drug Development Book Excerpt:

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.

The COVID 19 Pandemic

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

The COVID 19 Pandemic Book Excerpt:

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

Pediatric Drug Development

Pediatric Drug Development
Author: Andrew E. Mulberg,Steven A. Silber,John N. van den Anker
Publsiher: Wiley-Blackwell
Total Pages: 704
Release: 2009-04-13
ISBN: 9780470169292
Category: Medical
Language: EN, FR, DE, ES & NL

Pediatric Drug Development Book Excerpt:

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

PEDIATRIC CANCER THERAPEUTICS DEVELOPMENT

PEDIATRIC CANCER THERAPEUTICS DEVELOPMENT
Author: Anonim
Publsiher: Springer Nature
Total Pages: 184
Release: 2022
ISBN: 3031063570
Category: Electronic books
Language: EN, FR, DE, ES & NL

PEDIATRIC CANCER THERAPEUTICS DEVELOPMENT Book Excerpt:

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: 3319437542
Category: Medical
Language: EN, FR, DE, ES & NL

Fundamentals of Pediatric Drug Dosing Book Excerpt:

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 Research in Paediatric Psychopharmacology

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

Clinical Research in Paediatric Psychopharmacology Book Excerpt:

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

Pediatric Formulations

Pediatric Formulations
Author: Daniel Bar-Shalom,Klaus Rose
Publsiher: Springer Science & Business Media
Total Pages: 429
Release: 2014-01-30
ISBN: 1489980113
Category: Medical
Language: EN, FR, DE, ES & NL

Pediatric Formulations Book Excerpt:

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.

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: 0123878160
Category: Medical
Language: EN, FR, DE, ES & NL

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

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

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: 3805593635
Category: Medical
Language: EN, FR, DE, ES & NL

Guide to Paediatric Drug Development and Clinical Research Book Excerpt:

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.

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: 012417146X
Category: Medical
Language: EN, FR, DE, ES & NL

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

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

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: 451
Release: 2002-03-26
ISBN: 0824744802
Category: Medical
Language: EN, FR, DE, ES & NL

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

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.

Applications of Pharmacokinetic Principles in Drug Development

Applications of Pharmacokinetic Principles in Drug Development
Author: Rajesh Krishna
Publsiher: Springer Science & Business Media
Total Pages: 576
Release: 2004
ISBN: 9780306477669
Category: Medical
Language: EN, FR, DE, ES & NL

Applications of Pharmacokinetic Principles in Drug Development Book Excerpt:

This book presents a collection of articles that represent individual and expert perspectives in both preclinical and clinical development, including case studies on real-life examples of successful drugs that add value to the pharmacokinetic principles learned and applied. Unlike existing books that focus on pharmacokinetic theory, the current book emphasizes application of pharmacokinetic principles in new drug development.

Frontiers in Cardiovascular Drug Discovery Volume 4

Frontiers in Cardiovascular Drug Discovery  Volume 4
Author: Atta-ur-Rahman,M. Iqbal Choudhary
Publsiher: Bentham Science Publishers
Total Pages: 206
Release: 2019-04-05
ISBN: 1681084007
Category: Medical
Language: EN, FR, DE, ES & NL

Frontiers in Cardiovascular Drug Discovery Volume 4 Book Excerpt:

Frontiers in Cardiovascular Drug Discovery is an eBook series devoted to publishing the latest advances in cardiovascular drug design and discovery. Each volume brings reviews on the biochemistry, in-silico drug design, combinatorial chemistry, high-throughput screening, drug targets, recent important patents, and structure-activity relationships of molecules used in cardiovascular therapy. The eBook series should prove to be of great interest to all medicinal chemists and pharmaceutical scientists involved in preclinical and clinical research in cardiology. The fourth volume of the series covers the following topics: -Aspirin administration -Adenosine receptor targeting for cardiovascular therapy -Drug treatment of patients with coronary stenting -Immunosuppressive drugs in heart transplantation -PCSK9 inhibition for lowering LDL-C levels.

Drug Discovery and Development

Drug Discovery and Development
Author: Vishwanath Gaitonde,Partha Karmakar,Ashit Trivedi
Publsiher: BoD – Books on Demand
Total Pages: 166
Release: 2020-03-11
ISBN: 1789239753
Category: Medical
Language: EN, FR, DE, ES & NL

Drug Discovery and Development Book Excerpt:

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.

Drug Discovery and Development

Drug Discovery and Development
Author: Ramarao Poduri
Publsiher: Springer Nature
Total Pages: 522
Release: 2021-02-15
ISBN: 9811555346
Category: Medical
Language: EN, FR, DE, ES & NL

Drug Discovery and Development Book Excerpt:

This book describes the processes that are involved in the development of new drugs. The authors discuss the history, role of natural products and concept of receptor interactions with regard to the initial stages of drug discovery. In a single, highly readable volume, it outlines the basics of pharmacological screening, drug target identification, and genetics involved in early drug discovery. The final chapters introduce readers to stem therapeutics, pharmacokinetics, pharmacovigilance, and toxicological testing. Given its scope, the book will enable research scholars, professionals and young scientists to understand the key fundamentals of drug discovery, including stereochemistry, pharmacokinetics, clinical trials, statistics and toxicology.

Developmental and Reproductive Toxicology

Developmental and Reproductive Toxicology
Author: Ronald D Hood
Publsiher: CRC Press
Total Pages: 1168
Release: 2016-04-19
ISBN: 1841848212
Category: Medical
Language: EN, FR, DE, ES & NL

Developmental and Reproductive Toxicology Book Excerpt:

Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers evaluating and interpreting data. Originally titled Handbook of Developmental Toxicology, the second edition's new name reflects significant changes in its content and scope. New coverage in the Second Edition: Genomics and proteomics Tests for endocrine disruptors Testing for male and female reproductive toxicity Extensive treatment of the significance, reliability, and interpretation of developmental and reproductive toxicity data Toxicity testing in neonatal and juvenile animals Postnatal developmental milestones FDA perspective on risk assessment Extensive glossaries of developmental defect terminology Previous books on this subject have largely been academically oriented and not intended to guide the practicing developmental or reproductive toxicologist. Useful and informative, this book blends the theoretical foundation with insights gained from hands-on experience. It includes tables of comparative developmental milestones - both pre- and postnatal, glossaries of descriptive terms used in developmental toxicity evaluation, and both US and international regulatory guidelines. Bridging the gap between theory and application, this is a handy single-source of essential information to use in planning, conducting, and interpreting studies.

Recent Advances in Therapeutic Drug Monitoring and Clinical Toxicology

Recent Advances in Therapeutic Drug Monitoring and Clinical Toxicology
Author: Seth Kwabena Amponsah,Yashwant V. Pathak
Publsiher: Springer Nature
Total Pages: 384
Release: 2022-10-25
ISBN: 3031123980
Category: Medical
Language: EN, FR, DE, ES & NL

Recent Advances in Therapeutic Drug Monitoring and Clinical Toxicology Book Excerpt:

This book gives an overview of therapeutic drug monitoring (TDM) and its clinical application. It also highlights recent advances in toxicological studies, as they relate to therapeutic drug monitoring. This is one of the few books available on the market that covers TDM. Therapeutic drug monitoring (TDM) is a clinical decision-making tool that enables dosage regimen adjustments based on clinical and laboratory measurements. TDM not only involves the measuring of drug concentrations but also interpretation of the results. There is a strong correlation between drug concentrations in body fluids and outcome than between dose and outcome. The chapters include coverage of analytical techniques, pharmacokinetics, therapeutic indices, artificial intelligence and recent advances in toxicological studies. The book fills a gap in published literature and provides reliable information on; Analytical techniques in TDM and clinical toxicology TDM and pharmacokinetic studies TDM of drugs with narrow therapeutic indices Artificial intelligence in TDM and clinical toxicology Future directions and challenges

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
Author: Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
Publsiher: CRC Press
Total Pages: 318
Release: 2020-12-23
ISBN: 0429651139
Category: Medical
Language: EN, FR, DE, ES & NL

Current Topics in Nonclinical Drug Development Book Excerpt:

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.