title: Advances in pediatric pharmacology, therapeutics, and toxicology.
abstract: In the United States, passage of the FDASIA legislation made BPCA and PREA permanent, no longer requiring reauthorization every 5 years. This landmark legislation also stressed the importance of performing clinical trials in neonates when appropriate. In Europe the Pediatric Regulation, which went into effect in early 2007, also provides a framework for expanding pediatric clinical research. Although much work remains, as a result of greater regulatory guidance more pediatric data are reaching product labels.
authors.affiliation: Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, 301 Pharmacy Lane, Chapel Hill, NC 27599, USA; Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt Street, Durham, NC 27705, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Gonzalez
authors.affiliation: Department of Pediatrics, College of Medicine, Penn State University, 500 University Drive, HS83, Hershey, PA 17033, USA; Department of Public Health Sciences, College of Medicine, Penn State University, 500 University Drive, HS83, Hershey, PA 17033, USA.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Paul
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt Street, Durham, NC 27705, USA; Department of Pediatrics, College of Medicine, Duke University, T901/Children's Health Center, Durham, NC 27705, USA.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Benjamin
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt Street, Durham, NC 27705, USA; Department of Pediatrics, College of Medicine, Duke University, T901/Children's Health Center, Durham, NC 27705, USA. Electronic address: michael.cohenwolkowiez@duke.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Cohen-Wolkowiez
mesh_terms: D035843:Biomedical Research / Q000639:trends*; D002648:Child; D019468:Disease Management; D005060:Europe; D006801:Humans; D010372:Pediatrics / Q000639:trends*; D010601:Pharmacology, Clinical / Q000639:trends*; D014116:Toxicology / Q000639:trends*; D014481:United States
keywords: Pediatrics; Pharmacokinetics; Pharmacology; Toxicology