Changes in paediatric medicines research since the regulation

Dec 15, 2011

The publication Changes in Research and Development of Medicinal Products since the Paediatric Regulation is available on-line at the address http://www.intechopen.com/articles/show/title/changes-in-research-and-development-of-medicinal-products-since-the-paediatric-regulation.

The starting point is that medicines for paediatric population should be developed with the same level of scientific and clinical rigor as adult therapeutic products.

The state of art of paediatric medicines is well described in the paper. In fact, the publication provide a complete scenario of paediatric drugs research & development and their use, from non-clinical studies to pharmacovigilance, and explains how this scenario is going to be affected by the entry into force of the Paediatric Regulation.

This publication originates from the work carried out within the Network of Excellence TEDDY, Task-Force in Europe for Drug development for the Young, aimed at promoting the availability of safe and effective medicines for children in Europe by integrating existing expertise and good practices, as well as stimulating further developments.