Module232025

Challenges for Active Pharmaceutical Ingredients (APIs) in Pediatric Drug Development (1) 1.Limited APIs : Few pediatric-specific APIs; reliance on off-label or modified adult drugs increases risk of adverse effects. 2.Age-Specific PK/PD : Pediatric absorption, metabolism, and excretion vary; tailored formulations are essential. 3.Dosage Challenges : Weight, development, and organ maturity complicate accurate dosing adjustments. 4.Safety Issues : Potential toxicity and poorly studied long-term effects, especially in neonates and infants. 5.Adherence Factors : Taste, smell, and texture impact adherence; taste masking is often needed. 6.Formulation Needs : Age-appropriate forms (e.g., liquids, chewables) require advanced manufacturing techniques .

Quality (CMC) Development Considerations

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