Types of Safety-Related Data

In general, older patients handle many drugs differently from younger adult patients. While there are differences among drug classes, the usual consequence is increased toxicity (see Cairns, 2006, for further discussion). 

Various regulatory agencies around the world are working to increase the number of clinical trials involving children. The FDA s Office of Pediatric Therapeutics focuses on both clinical and ethical aspects of clinical research in pediatric populations and works to increase the scientific understanding of the medical needs of children. 

Because of differences in pharmacokinetics in infants and children, it may not be appropriate simply to proportionately reduce the adult dose. If it is available, the most reliable pediatric dose information available is usually the information provided by the manufacturer in the package insert however, this information is not available for the majority of products (Koren, 2004). Recently, the FDA has moved toward more explicit expectations that sponsors conduct appropriate clinical evaluations of new products in infants and children. (See also http //www.fda.gov/ cder/pediatric/Summaryreview.htm). 

The issue of pediatric drug evaluation is considered again in Section 14.10 when discussing the FDA s March 2006 Critical Path Opportunities List Pediatrics is the sixth item on this list. 

13 Types of Safety-Related Data Safety-related data can be considered at three levels  

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