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.
- 164 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
Guide to Paediatric Clinical Research
About this book
Trusted by 375,005 students
Access to over 1.5 million titles for a fair monthly price.
Study more efficiently using our study tools.
Information
Table of contents
- Cover
- Contents
- Introduction from the Editors
- The Editors
- Authors’ Short Biographies
- Authors’ Addresses
- Europe’s Path towards Better Medicines for Children
- The European Academy of Paediatrics (EAP/ CESP) and Its Demand for More Clinical Research
- Paediatric Medicines: A View from Patient Organisations
- Paediatric Drug Development – Historical Background of Regulatory Initiatives
- ICH E 11: Clinical Investigation of Medicinal Products in the Paediatric Population: The International Guidance on Clinical Drug Development in Children
- Ethical Challenges of Clinical Research in Children
- Consent and Assent in Paediatric Clinical Trials
- Collecting Blood and Tissue Samples in Paediatric Clinical Trials
- Paediatric Formulations
- Central Laboratory in Paediatric Clinical Trials
- Study and Protocol Design for Paediatric Patients of Different Ages
- Innovative Methodologies for Drug Evaluation in Children
- Challenges in the Research of Very Small Children
- Clinical Research for Infant Nutrition
- Conclusions: Paediatric Drug Development in a Global Context
- Author Index
- Subject Index
Frequently asked questions
Yes, you can cancel anytime from the Subscription tab in your account settings on the Perlego website. Your subscription will stay active until the end of your current billing period. Learn how to cancel your subscription
No, books cannot be downloaded as external files, such as PDFs, for use outside of Perlego. However, you can download books within the Perlego app for offline reading on mobile or tablet. Learn how to download books offline
Perlego offers two plans: Essential and Complete
- Essential is ideal for learners and professionals who enjoy exploring a wide range of subjects. Access the Essential Library with 800,000+ trusted titles and best-sellers across business, personal growth, and the humanities. Includes unlimited reading time and Standard Read Aloud voice.
- Complete: Perfect for advanced learners and researchers needing full, unrestricted access. Unlock 1.5M+ books across hundreds of subjects, including academic and specialized titles. The Complete Plan also includes advanced features like Premium Read Aloud and Research Assistant.
We are an online textbook subscription service, where you can get access to an entire online library for less than the price of a single book per month. With over 1.5 million books across 990+ topics, we’ve got you covered! Learn about our mission
Look out for the read-aloud symbol on your next book to see if you can listen to it. The read-aloud tool reads text aloud for you, highlighting the text as it is being read. You can pause it, speed it up and slow it down. Learn more about Read Aloud
Yes! You can use the Perlego app on both iOS and Android devices to read anytime, anywhere — even offline. Perfect for commutes or when you’re on the go.
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app
Yes, you can access Guide to Paediatric Clinical Research by K. Rose,J. N. van den Anker, Rose, van den Anker in PDF and/or ePUB format, as well as other popular books in Medicine & Perinatology & Neonatology. We have over 1.5 million books available in our catalogue for you to explore.