IQ Collaborates with University of Maryland Center for Excellence in Regulatory Science
Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow, a two-day workshop sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) in collaboration with IQ Consortium.
Pediatric drug development continues to be an increasingly important topic for the pharmaceutical industry and global regulatory agencies. This two-day workshop will discuss formulation, analytical, and clinical elements of pediatric drug development, including regulatory and industrial perspectives.
Formulation elements to be discussed include:
- Strategies for co-packaging of drug products with devices (customized and off-the shelf).
- Safety and use of non-compendia excipients in pediatric patient population and application of database of pediatric excipients.
- Acceptability assessment (swallowability, mouthfeel and texture) of pediatric drug product and proposal for harmonized methodology for acceptability assessment.
Analytical elements to be covered include:
- Evaluation and validation requirements for dosing vehicles (compatibility, stability, and in-use).
- Specifications for multiparticulates: granules, mini-tablets, and pellets.
Clinical elements to be highlighted include:
- Pediatric PK, including unique patient population characteristics.
- Study designs, including methodology considerations.
- Biostudies to support formulation development.
Regulatory and industrial perspectives will include:
- Lessons learned during review of PIP/PSP by regulatory agencies and guidance for age-appropriate formulations.
- Future landscape and challenges, questions, and gaps encountered by industry in the development of age-appropriate formulations.