PEDIATRIC LABELING REQUIREMENTS - IMPLICATIONS FOR PHARMACOKINETIC STUDIES

The US Food and Drug Administration (FDA) has proposed new labelling r egulations that describe alternative approaches for providing addition al information to support labelling a drug, already approved for use i n adults, for use in children. Therefore, the study of drugs in paedia tric populations may now be encouraged. Paediatric pharmacokinetic stu dies are an important part of these trials. This action by the FDA may help resolve the ethical and technological concerns about the perform ance of clinical trials in children, and may render paediatric clinica l trials more feasible. Most investigations in children are opportunis tic in nature and their design is often constrained by a requisite non invasive approach. Appropriately applied population-based techniques f or both pharmacokinetic and pharmacodynamic data analysis may represen t the most robust approach for generating a sufficiently large and acc urate database for the use of new or old drugs in paediatric patients. Accordingly, this information, which is crucial for paediatric labell ing of any drug product, must be obtained in infants and children if w e are to truly individualise therapy for paediatric patients. The fund ing of 6 Pediatric Pharmacology Research Units by the US National Inst itutes of Health, and guidelines for application of pharmacokinetic me thods to children may further contribute to the performance of paediat ric clinical trials.