Summary of the National Institute of Child Health and Human Development-Best Pharmaceuticals for Children Act Pediatric Formulation Initiatives Workshop-Pediatric Biopharmaceutics Classification System Working Group

Division of Pediatric Pharmacology and Medical Toxicology, The Children's Mercy Hospital, Kansas City, Missouri.
Clinical Therapeutics (Impact Factor: 2.73). 11/2012; 34(11):S11-S24. DOI: 10.1016/j.clinthera.2012.09.014
Source: PubMed


The Biopharmaceutics Classification System (BCS) allows compounds to be classified based on their in vitro solubility and intestinal permeability. The BCS has found widespread use in the pharmaceutical community to be an enabling guide for the rational selection of compounds, formulation for clinical advancement, and generic biowaivers. The Pediatric Biopharmaceutics Classification System (PBCS) Working Group was convened to consider the possibility of developing an analogous pediatric-based classification system. Because there are distinct developmental differences that can alter intestinal contents, volumes, permeability, and potentially biorelevant solubilities at different ages, the PBCS Working Group focused on identifying age-specific issues that need to be considered in establishing a flexible, yet rigorous PBCS.

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