title: Drug development process for a product with a primary pediatric indication.
abstract: This article reviews the drug development process in the United States, focusing on practical issues and new U.S. Food and Drug Administration (FDA) regulations and guidance for developing a drug with a primary pediatric indication. Atomoxetine, a novel treatment for attention-deficit/ hyperactivity disorder (ADHD), is used to illustrate how the modern drug development process works and to highlight changes in the development of ADHD treatments since the introduction of the stimulants over 50 years ago. In addition to dealing with unique regulatory requirements and guidance, developing a drug for use in a pediatric population poses novel challenges in diverse areas including biomedical ethics, developmental pharmacology, and clinical trial design and implementation.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. allenaj@lilly.com
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Allen
authors.forename: David
authors.initials: D
authors.lastname: Michelson
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D000697:Central Nervous System Stimulants / Q000627:therapeutic use; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D015507:Drugs, Investigational / Q000592:standards / Q000627:therapeutic use*; D006801:Humans; D010372:Pediatrics / Q000331:legislation & jurisprudence*; D011437:Propylamines / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000928:Antidepressive Agents; D000697:Central Nervous System Stimulants; D015507:Drugs, Investigational; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride