Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Zimmerman KO

Duke Clinical Research Institute,
Box 3352, Durham, North Carolina 27710
United States

  • Review Article
    Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity
    Author(s): Zimmerman KO, Benjamin Jr. DK, Becker ML, Anand R and Hornik CPZimmerman KO, Benjamin Jr. DK, Becker ML, Anand R and Hornik CP

    Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product labels largely fail to include dosing or guidance specific to this population. Failure to include this information results in an increased incidence of adverse events, and concerns from treating physicians regarding their ability to provide appropriate care for children with obesity. Using data from the National Institute of Child Health and Human Development-funded Pediatric Trials Network (PTN), we explore possible ways to improve drug labeling in children with obesity. In order to improve health outcomes of children with obesity, carefully designed and executed PK trials and comprehensive PK analysis strategies are needed. Early coll.. Read More»

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