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Drug Development for Pediatric Populations: Regulatory Aspects
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Pediatric Dosing and Body Size in Biotherapeutics

Department of Pharmaceutics, University of Florida, Gainesville, FL, 32610, USA
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Pharmaceutics 2010, 2(4), 389-418; https://doi.org/10.3390/pharmaceutics2040389
Received: 26 October 2010 / Revised: 9 December 2010 / Accepted: 15 December 2010 / Published: 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. View Full-Text
Keywords: pediatric; dosing; proteins; peptides pediatric; dosing; proteins; peptides
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MDPI and ACS Style

Shi, R.; Derendorf, H. Pediatric Dosing and Body Size in Biotherapeutics. Pharmaceutics 2010, 2, 389-418. https://doi.org/10.3390/pharmaceutics2040389

AMA Style

Shi R, Derendorf H. Pediatric Dosing and Body Size in Biotherapeutics. Pharmaceutics. 2010; 2(4):389-418. https://doi.org/10.3390/pharmaceutics2040389

Chicago/Turabian Style

Shi, Rong; Derendorf, Hartmut. 2010. "Pediatric Dosing and Body Size in Biotherapeutics" Pharmaceutics 2, no. 4: 389-418. https://doi.org/10.3390/pharmaceutics2040389

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