Module232025

Challenges of Excipients in CMC for Pediatric Drugs (2) 7.Formulation Needs : Excipient selection must suit pediatric-specific formulations like liquids or chewables. 8.Cultural Preferences : Flavor and appearance should align with regional preferences to improve adherence. 9.Stability and Shelf Life : Liquid formulations often need excipients for stabilization and contamination prevention. 10.Storage Challenges : Excipients requiring refrigeration can limit usage in resource-poor areas. 11.Regulatory Requirements : EMA/FDA demand extensive safety data, slowing approval processes. 12.Global Standardization : Lack of harmonized excipient standards complicates worldwide drug development. Addressing Challenges : Initiatives like STEP streamline excipient safety data for pediatric formulation development.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs