title: Drug development for children: how is pharma tackling an unmet need?
abstract: The laws and regulatory processes that govern the pharmaceutical industry have previously had the unintended consequence of excluding children in the drug development process. Many of the medicines prescribed to children consist of either an unlicensed form of a launched drug or an off-label form (ie, a form outside of the terms of the license, such as in an unapproved dose or for use in a different disease or age group). Medicines prescribed to children in such ways may have an increased risk of causing adverse drug reactions. New legislation in the EU, along with legislation in the US, provide the pharmaceutical industry with positive financial incentives to consider children in the drug development process. From the stage of identifying new molecular entities, to juvenile animal testing, to phase I to IV clinical trials and formulation development, industry practice has improved in several areas with relation to pediatrics; however, other areas remain to benefit from these legislative changes.
authors.affiliation: Division of Child Health, School of Reproductive and Developmental Medicine, University of Liverpool, Alder Hey Children's Hospital, Liverpool, L12 2AP, UK.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Hawcutt
authors.forename: Rosalind L
authors.initials: RL
authors.lastname: Smyth
mesh_terms: D002648:Child; D015195:Drug Design; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D010372:Pediatrics; D004364:Pharmaceutical Preparations; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations