Module232025

General Challenges in Chemistry, Manufacturing, and Control (CMC) for Pediatric Drug Development: 1.Age-Specific Formulations : Tailored to pediatric groups considering physiology and swallowing abilities. 2.Palatability : Taste masking is essential for better adherence. 3.Flexible Dosages : Adjustable forms based on age, weight, and development. 4.Excipient Safety : Limited data; risks with immature metabolism. 5.Stability : Challenges with liquid formulations, refrigeration, and shelf life. 6.PK/PD Variability : Differences in drug processing require precise dosing. 7.Regulatory Compliance: Pediatric CMC practices must meet stricter EMA/FDA requirements. 8.Scalability: Small trial batches must scale for niche commercial manufacturing. 9.Economic Challenges: High costs and small market size limit profitability. 10.Friendly Delivery: Develop child-friendly dosing tools like droppers or spoons. 11.Tech Advancements: Use innovations like nanomedicine, to address scaling challenges.

We will provide further elaboration, including detailed explanations and examples, throughout this course.

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs