Book Reviews

Guide to Paediatric Drug Development and Clinical Research

K. Rose and J. N. van den Anker.

S. Karger AG, Basel, Switzerland (2010).

ISBN 978-3-8055-9362-5.

XX and 222 pages, 19 figures, 23 tables,

hardcover. Price: 荤 115.50/

USD 162.00 / CHF 162.00

(prices subject to change).

Increasing attention is paid to drug treatment of children and the development of respective drugs worldwide. Actions are taken by legislation and regulatory authorities in many areas and countries. This book gives an overview over the worldwide activities that include children in the development of new medicines. The main sections are

• The global framework of paediatric drug development: Legal and regulation initiatives in Europe, United States and Japan; ethical imperatives; patient's perspective; global access to essential medicines.

• Paediatric clinical pharmacology: Development of paediatric medicines and development plans; role of clinical pharmacology.

• Practical and ethical challenges: EMA paediatric website; investigation plan elements; ethics in paediatric research; consent and assent in clinical trials; patients of different age; collection of blood and tissue samples.

• General and specific scientific challenges: Strength of evidence; paediatric formulations; oral paediatric formulations; pharmacovigilance in research and development; non-clinical safety assessment; critical care.

• Disease-specific challenges: Paediatric oncology; cancer treatment in Africa; research in immunology and inflammation; clinical trials of anti-infective agents; obesity; familial dyslipidaemia; anti-hypertensive clinical trials; vaccination trials.

• Future of the paediatric pharmaceutical market

The activities to include children in the development of medicines in general as well as to incite the development of special medicines dedicated to children are still growing and widening. Researchers in drug development and pharmaceutical companies are affected in the first place. Readers from this field will especially benefit from this book because recent regulations state mandatory demands for research in children and submission of respective data for a wide variety of existing and future drugs.

(ECV)