ABSTRACT
INTRODUCTION A paradigm shift is taking place from protecting children against clinical research to protecting them through research (1). This is based on the right of children to safer and more effective medicines, the overall increase in the role of medicines in disease management, and the better use of information pertaining to the physiology of children (1). It is recognized that there are challenges in optimizing the development, availability, and routine use of effective, safe, and affordable medicines for children (2). Initiatives such as the World Health Organization’s (WHO) campaign “make medicines child size” in December 2007 and the International Alliance for Better Medicines for Children in 2006, and initiatives by the European Medicines Evaluation Agency (EMEA) and the Food and Drug Administration (FDA) in the USA to regulate and give incentives to the pharmaceutical industry to conduct pediatric clinical trials for new investigational drugs have spurred a global drive to produce more and better medicines specifically for children. A better understanding of how children differ from adults with respect to drug absorption and use of this information to design more appropriate dosage forms for children are integral components of these initiatives.
