Next Article in Journal
The Influence of Milling on the Dissolution Performance of Simvastatin
Next Article in Special Issue
The Pharmacokinetics and Pharmacodynamics of Iron Preparations
Previous Article in Journal / Special Issue
Drug Development for Pediatric Populations: Regulatory Aspects
Pharmaceutics 2010, 2(4), 389-418; doi:10.3390/pharmaceutics2040389

Pediatric Dosing and Body Size in Biotherapeutics

Department of Pharmaceutics, University of Florida, Gainesville, FL, 32610, USA
* Author to whom correspondence should be addressed.
Received: 26 October 2010 / Revised: 9 December 2010 / Accepted: 15 December 2010 / Published: 16 December 2010
View Full-Text   |   Download PDF [284 KB, uploaded 16 December 2010]   |  


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.
Keywords: pediatric; dosing; proteins; peptides pediatric; dosing; proteins; peptides
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

Share & Cite This Article

Further Mendeley | CiteULike
Export to BibTeX |
EndNote |
MDPI and ACS Style

Shi, R.; Derendorf, H. Pediatric Dosing and Body Size in Biotherapeutics. Pharmaceutics 2010, 2, 389-418.

View more citation formats

Related Articles

Article Metrics

For more information on the journal, click here


[Return to top]
Pharmaceutics EISSN 1999-4923 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert