- The Pediatric Drug Development Process
- Challenges in PDD – Developmental physiology & PK
- Formulation and CMC Factors to consider in PDD
Pediatric patients are among the most vulnerable and the most challenging patient population for treatment due to age related changes in developmental physiology and ADME characteristics. Safety, product design, dispensation and palatability of dosage forms are critical CMC considerations in developing age-appropriate dosage forms for pediatric populations.
- Choice of excipients and additives in formulation is guided by safety and intake limits, duration of treatment and regulatory acceptance
- Drug substance stability, compatibility and ADME profile from adult program can be reasonably adapted for pediatric drug development
- Product design and user experience are key to developing a target product profile (TPP) that ensures safety, quality and patient compliance
Raman Iyer, Associate Director, Technical R&D, Novartis Pharmaceuticals Corp.