Strategies for Accelerating Pediatric Drug Development
Overview
Developing pediatric medicines presents unique challenges, including age-appropriate formulations, dose flexibility, and regulatory compliance across global markets.
Regulatory frameworks such as the EMA Pediatric Investigation Plan (PIP) and FDA Pediatric Study Plan (PSP) require proactive planning for pediatric drug programs to avoid delays. Key considerations when developing effective pediatric formulations include:
- Conducting an early biopharmaceutics classification of the molecule to inform development decisions
- Selecting suitable dosage forms for the pediatric formulation—such as mini-tablets, liquids, or dispersible formulations
- Leveraging physiologically based pharmacokinetic (PBPK) modeling to predict dosing and optimize clinical trial design
- Conducting a palatability assessment and implementing taste-masking technologies to improve patient compliance
By adopting integrated development strategies and advanced modeling tools, pharmaceutical companies can reduce timelines and deliver safe, effective therapies for children.
Read our whitepaper to see the potential solutions to address pediatric formulation development challenges along with future trends and regulatory aspects that can help streamline the development and delivery of effective pediatric medicines to patients.