Upper respiratory infections and allergic rhinitis are common diseases in children. In recent years, U.S. Food and Drug Administration has been promoting pediatric drug development with marketing exclusivity incentives and requirements. The assessment of clinical pharmacology, efficacy, and safety data has facilitated pediatric drug development and provided appropriate labeling for pediatric use. Regulatory decision making involves multiple evaluation processes, including drug exposure comparison between adult and pediatric population, formulation bridging, dose selection, and evaluation of efficacy and safety in pediatric patients. This article reviews the pediatric drugs indicated for cough, cold, and allergic rhinitis, focusing on the utility of clinical pharmacology, safety, and efficacy data in determining the pediatric dosing regimen and the approaches taken for regulatory decision making.
Keywords: Allergic rhinitis; Clinical Pharmacokinetics; Clinical pharmacology; Cough and cold; Pediatrics; Pharmacodynamics; Pharmacokinetics; Population Pharmacokinetics.
© 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.