Module232025

Challenges for Active Pharmaceutical Ingredients (APIs) in Pediatric Drug Development (2) 7.Stability Issues : APIs may degrade in pediatric-friendly forms, requiring stabilization via excipients. 8.Regulatory Hurdles : Strict safety/efficacy studies complicate timelines; fewer pediatric clinical trials due to ethical and recruitment challenges. 9.Economic Challenges : Smaller market size discourages investment and slows innovation in pediatric APIs. 10.Global Access Barriers : Varying approval processes limit availability, especially in low-resource regions. 11.Technological Gaps : Scale-up and long-term application uncertainties for advanced therapies like nanomedicine. 12.Addressing Issues : Incentives like Pediatric Use Marketing Authorization (PUMA) and collaboration among developers, regulators, and researchers to improve pediatric drug development.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs