Characterizing mAb PK in pediatrics, especially in younger children, is challenging given limited data availability due to logistic and ethical restraints. Currently, dose recommendation is usually based on simple allometric scaling only accounting for the effect of body size. However, additional critical factors including organ maturation are not studied as extensively. Our work aims to understand the physiological changes in infants impacting mAb absorption, distribution and elimination, evaluate the role of maturation function in characterizing mAb PK in infants, and provide insight to PK modeling, study design and ultimately dose recommendation. The presentation will provide a systematic overview summarizing the physiological factors relevant to mAb PK in pediatrics and the mathematical approaches describing maturation, followed by a case study highlighting the quantitative impact of maturation function on mAb PK and the downstream impacts on study design and dose selection in infants.
Obtain an overview of the physiological factors impacting mAb absorption, distribution and elimination in infants
Understand the potential limitations of body weight based allometric scaling in describing and predicting mAb PK in infants
Learn when and how maturation functions need to be included in mAb PK models