When dealing with drug use in children, almost all aspects of metabolism are immature. This includes pharmacokinetic (PK) variables. There is also a great difference in term of drug pharmacodynamics (PD) between children and adults. This immature state is not static as maturational changes occur with advancing age. Paradoxically, a supposedly immature organ may be maturely adapted for a specific function at a given time of its development and can therefore be more affected by some drugs. Due to the lack or inadequacy of pharmacological information in the paediatric population, a suboptimal use of many drugs defined as unlicensed or ‘off-label’ has been the rule till now. It gave rise to an unacceptable risk of adverse events (AE) in children. The only way to ameliorate this state of fact was found to perform well-designed clinical trials in different paediatric sub-groups. It has very important ethical issues which must always be kept in mind. All procedures used to minimize risks and to get optimal benefits must be justified. Different guidelines and concept papers initiated under the umbrella of the European Drug Agency (EMEA) will intend to highlight specific needs when performing a full drug development programme in a given paediatric population. The European regulation in term of drug development is entering into force in 2007. It will help maximizing the paediatric pharmacology needs in conjunction with academics, learned societies and pharmaceutical companies.
Learning objectives
After viewing this presentation the participant will be able to discuss:
- Fundamental principles of Developmental Pharmacology
- Basic features of the new European Regulation in terms of Drug Development in Children.
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