Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow
Tuesday, June 18, 2019
8:00 a.m.-5:30 p.m.
University of Maryland School of Pharmacy, 20 N. Pine Street, Baltimore Maryland 21201
301 405 0285
About the two-day event: June 18-19
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.
Ultimately, this workshop will enable:
- Sharing of current knowledge, practices, issues, and challenges in pediatric drug development.
- Exchanges of pediatric development approaches in the areas of age appropriate formulation, validation and specification requirements for pediatric drug product, clinical strategies to accelerate pediatric drug development, and regulatory and industry considerations.
- Identification of best practices to generate appropriate data during development of paediatric formulations for global use.
If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen (firstname.lastname@example.org) at least 7 days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: email@example.com.