Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

In a pediatric protocol, knowing drug clearance data is crucial for understanding which group’s maturity?

1. Infants

2. Children

3. Adolescents

4. Newborns

The correct answer is: Children

Understanding drug clearance in the context of pediatric protocol is vital for determining the metabolic capabilities and physiological maturity of children. As children grow, their organ systems, including liver and kidneys, develop significantly, impacting how drugs are metabolized and eliminated from the body. In infancy, particularly in the newborn stage, clearance rates can be substantially different due to immature organ systems. While it’s important to consider drug clearance for infants and newborns, the focus here on children relates to how their growing bodies can handle medications more similarly to adults as they reach certain developmental milestones. In this context, children (typically defined as those from 1 year to 12 years of age) undergo significant growth and physiological changes, which means their drug clearance rates often approach those of adults. Therefore, understanding clearance data in the group identified as children provides insight into the effects of maturation on pharmacokinetics essential for drug dosing and efficacy. Infants are still considered in earlier developmental stages where clearance is not fully at adult levels, and adolescents might demonstrate different pharmacokinetics due to the beginning of adult physiology but are not the target group in this instance. Hence, focusing on children offers the most precise understanding of how drug clearance data informs maturity across the relevant age group.