Pediatric Infectious Diseases: Open Access

Dosing in Biotherapeutics for Children and Body Size

Although paediatric biotherapeutic doses are frequently calculated using the patient's body weight (mg/kg) or body surface area (mg/m2), linear body size dosage adjustment is extremely empirical. In paediatrics, growth and maturity are also key factors that influence biologic absorption, distribution, metabolism, and excretion (ADME). The complexity of the parameters involved in paediatric pharmacokinetics necessitates a rethinking of dose adjustment depending on body size. When opposed to no dose adjustment, a proper paediatric dosing adjustment should result in less intersubject variability in the product's pharmacokinetics and/or pharmacodynamics. Small molecules and biological proteins and peptides have a similar pharmacokinetic principle, although the underlying mechanism can be extremely different. For a number of biotherapeutics, paediatric and adult pharmacokinetic properties are compared and summarised. In this review, the impact of body size on paediatric pharmacokinetics for these biological products is examined.

John Derendorf