| The American Academy of Pediatrics recognized that failure to conduct pediatric drug research may deprive children of significant therapeutic advances. However, several ethical questions need to be addressed if we continue to undertake pediatric drug research. In studies requiring repeated blood sampling, issues of potential risk, invasiveness, and pain management strategies need to be addressed. To characterize the pharmacokinetic parameters of amlodipine in children, a population pharmacokinetic design was utilized in order to address the issue of repeated blood sampling. Subsequently, a comparative bioavailability study of two formulations of amlodipine was completed in adult volunteers instead of a pediatric population due to ethical concerns. In order to offer additional pain treatment options for children before blood sampling procedures, the topical local anaesthetic amethocaine was studied in adults. This thesis attempts to show that research in children is ethically defensible, but adults must sometimes be used to answer pediatric research questions. |
