Module232025

Administration Route and Pharmaceutical Dosage Forms in Pediatrics (2)

Key Considerations :

o Suitable dosing volumes: ≤ 5 mL for under 5 years, ≤ 10 mL for older children. o Stability: Liquid formulations often require refrigeration, posing challenges in low-resource settings. o Safety of excipients: Critical for pediatric formulations; some (e.g., ethanol) may harm children. Emerging Solutions : (PCDPD) and Quality Target Product Profiles (QTPPs) guide safer, tailored drug development. o Patient-centric design processes

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs