Guide to Paediatric Drug Development and Clinical Research

2010-01-01
 |  Medical
Guide to Paediatric Drug Development and Clinical Research

Author: Klaus Rose

Publisher: Karger Medical and Scientific Publishers

ISBN: 9783805593625

Category: Medical

Page: 240

View: 544

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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.

Guide to Paediatric Clinical Research

2007
 |  Medical
Guide to Paediatric Clinical Research

Author: Klaus Rose

Publisher: Karger Medical and Scientific Publishers

ISBN: 9783805582018

Category: Medical

Page: 164

View: 235

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As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.

Considering the Patient in Pediatric Drug Development

2020-11-19
 |  Business & Economics
Considering the Patient in Pediatric Drug Development

Author: Klaus Rose

Publisher: Academic Press

ISBN: 9780128242056

Category: Business & Economics

Page: 414

View: 160

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Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents. Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information

Pediatric Formulations

2014-01-30
 |  Medical
Pediatric Formulations

Author: Daniel Bar-Shalom

Publisher: Springer Science & Business Media

ISBN: 9781489980113

Category: Medical

Page: 429

View: 874

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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.

Pediatric Drug Development

2011-09-20
 |  Medical
Pediatric Drug Development

Author: Andrew E. Mulberg

Publisher: John Wiley & Sons

ISBN: 9781118210437

Category: Medical

Page: 932

View: 157

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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 Clinical Pharmacology

2011-09-01
 |  Medical
Pediatric Clinical Pharmacology

Author: Hannsjörg W. Seyberth

Publisher: Springer Science & Business Media

ISBN: 9783642201950

Category: Medical

Page: 385

View: 206

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The objective of this volume is to give an overview of the present state of the art of pediatric clinical pharmacology including developmental physiology, pediatric-specific pathology, special tools and methods for development of drugs for children (assessment of efficacy, toxicity, long-term safety etc.) as well as regulatory and ethical knowledge and skills. In the future, structural and educational changes have to lead back to a closer cooperation and interaction of pediatrics with (clinical) pharmacology and pharmacy.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

2012-11-02
 |  Medical
A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi

Publisher: Academic Press

ISBN: 9780123878151

Category: Medical

Page: 904

View: 183

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A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. Intended as a comprehensive resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations (CRO), this book will discuss discovery toxicology and the international guidelines for safety evaluation and present both traditional and nontraditional toxicology models. By incorporating the latest research in this area and featuring real-life examples and scenarios, this reference is a complete and practical 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. Incorporates real-life case studies and examples and offers readers a practical resource that outlines day-to-day activities and experiences in preclinical toxicology.

Clinical Pharmacology: Current Topics and Case Studies

2016-03-15
 |  Medical
Clinical Pharmacology: Current Topics and Case Studies

Author: Markus Müller

Publisher: Springer

ISBN: 9783319273471

Category: Medical

Page: 405

View: 158

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This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.

Pharmaceutical Formulation

2018-06-25
 |  Science
Pharmaceutical Formulation

Author: Geoffrey D Tovey

Publisher: Royal Society of Chemistry

ISBN: 9781849739412

Category: Science

Page: 432

View: 152

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Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

Translational Stem Cell Research

2010-12-25
 |  Science
Translational Stem Cell Research

Author: Kristina Hug

Publisher: Springer Science & Business Media

ISBN: 9781607619598

Category: Science

Page: 462

View: 885

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For many years, the ethical discussion surrounding human embryonic stem cell research has focused on the moral status of the embryo. This text takes a wider moral berth and focuses on numerous ethical, legal and social aspects involved in translating the results of stem cell research into diagnostic and therapeutic applications. Translational Stem Cell Research is broken into ten sections. It opens with an overview of the latest in stem cell research, focusing on specific diseases and the treatment of burn victims. Part II discusses the issues involved in the many steps from bench to bedside, ranging from first research in vitro to clinical trials. Part III covers scientific, regulatory and ethical challenges to basic research, and Part IV details issues regarding stem cell banks. Part V explores ethical, economic and strategic issues involved in collaboration between universities and industry, and Part VI addresses legal problems raised by patents on human stem-cell based inventions plus the extent to which there can be technological solutions to a moral dilemma. Part VII presents imaginative ways of communicating research to the general public and how to create conditions for a constructive dialogue. Part VIII probes psychosocial and cultural factors affecting judgment and decisions about translational stem cell research, and Part IX explores problems and procedures raised by an examination of the evaluation of stem cell research projects in research ethics committees. The book closes with a look into the future of translational stem cell research and stem cell-based therapeutic applications.

Pediatric Drug Development

2013-05-20
 |  Medical
Pediatric Drug Development

Author: Andrew E. Mulberg

Publisher: John Wiley & Sons

ISBN: 9781118312056

Category: Medical

Page: 624

View: 654

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Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.

Essentials of Translational Pediatric Drug Development

2023-01-17
 |  Business & Economics
Essentials of Translational Pediatric Drug Development

Author: Elke Gasthuys

Publisher: Academic Press

ISBN: 0323884598

Category: Business & Economics

Page: 670

View: 104

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Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. Essentials of Translational Pediatric Drug Development: From Past needs to Future Opportunities provides integrated up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects of pediatric drug development from different stakeholder perspectives and will provide a literature overview and careful reflection of the state-of-the-art approaches that are used. The book will be a guide for researchers in the field to design and to perform high quality, innovative pediatric-adapted drug development by defining needs/challenges as well as possible solutions to advance and to harmonize pediatric drug development. Covers both theoretical and practical aspects of translational pediatric drug development Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians, patient/parent advocacy groups) Offers best practices and future perspectives for improvement of translational pediatric drug development