Dosing regimen determination for juvenile idiopathic arthritis: a review of studies during drug development.
Juvenile idiopathic arthritis (JIA) is the most common childhood arthritis. In the past 10-15 years, the medical treatment options of JIA have greatly evolved and expanded due to a better understanding of the disease and the application of biologic agents. Regulations pertinent to pediatric clinical research have also helped provide a legal basis for investigating the effects of drugs and biologics in pediatrics and facilitate the pediatric drug development. The evaluation of clinical pharmacology, efficacy, and safety has provided valuable labeling information for pediatric use, including comparing exposure between adult and pediatric patients, bridging different formulations and regimens, providing appropriate dose selection recommendation with the modeling and simulation approach, and assessing the risks and benefits. This review summarizes the drugs and biologics with JIA labeling implications and discusses the application of clinical pharmacology, safety, and efficacy assessment in determining pediatric dosing regimens.
Division of Clinical Pharmacology II, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ping
P
Ji
Badrul A
BA
Chowdhury
Sarah
S
Yim
Chandrahas G
CG
Sahajwalla
D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D055808:Drug Discovery; D054796:Drug Dosage Calculations; D006801:Humans
D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents