Pediatric Dosing and Body Size in Biotherapeutics

Pharmaceutics

Rong Shi¹ 

[1] Department of Pharmaceutics, University of Florida, Gainesville, FL, 32610, USA; E-Mail

关键词: pediatric;    dosing;    proteins;    peptides;   

DOI  :  10.3390/pharmaceutics2040389

来源: mdpi

【 摘 要 】

Although pediatric doses for biotherapeutics are often based on patients' body weight (mg/kg) or body surface area (mg/m²), linear body size dose adjustment is highly empirical. Growth and maturity are also important factors that affect the absorption, distribution, metabolism and excretion (ADME) of biologics in pediatrics. The complexity of the factors involved in pediatric pharmacokinetics lends to the reconsideration of body size based dose adjustment. A proper dosing adjustment for pediatrics should also provide less intersubject variability in the pharmacokinetics and/or pharmacodynamics of the product compared with no dose adjustment. Biological proteins and peptides generally share the same pharmacokinetic principle with small molecules, but the underlying mechanism can be very different. Here, pediatric and adult pharmacokinetic parameters are compared and summarized for selected biotherapeutics. The effect of body size on the pediatric pharmacokinetics for these biological products is discussed in the current review.

【 授权许可】

CC BY   
© 2010 by the authors; licensee MDPI, Basel, Switzerland.