A research agenda for the study of therapeutic agents in adolescents

Without an understanding of the developmental factors which initiate functional changes in the adolescent's capacity for drug disposition, the choice of any developmental measure (e.g., Tanner staging) to include in a focused research effort is premature. The role of growth and gender in pubertal functional change must be delineated. In addition, research must target clinically relevant pharmacokinetic changes resulting from this functional development and relate these to modifications of drug effect (i.e., using effect-controlled trials rather than concentration-controlled trials). Such studies could define population characteristics associated with pubertal development that produce pharmacodynamic changes. Drug effect in the adolescent, particularly at the receptor level, needs study. A strategy for the systematic evaluation of these issues is discussed.