Live webinar - Developing Palatable Pediatric Formulations: Leveraging taste masking, modelling & simulation, clinical PK and taste assessment studies to achieve program success
3PM LONDON / 10AM NEW YORK
The demand for pediatric dosage forms continues to increase however the number of approved pediatric drug treatments on the market remains substantially less than those for adults.
Developing drug products for pediatric patients brings a whole set of unique challenges for development teams; the broad spectrum of age ranges means that multiple product formats and/or versatile formulations may be required, and the swallowability, palatability and size of the dosage form will have a direct impact on patient compliance and hence the therapeutic benefits derived.
Pediatric dosage forms can greatly differ from drug products designed for adult use. Development scientists must consider the route of administration, the safety profile, overall taste and palatability, the child’s age, weight, physiologic condition, and the treatment plan’s requirements.
All these key factors must be balanced for developing a paediatric product that garners clinical, regulatory and commercial success.
Key Discussion Topics and Case Studies:
- Regulatory considerations
- Patient-centric dosage forms
- The importance of taste masking, taste modification and alternate dosage forms
- PBPK modelling and simulation for dose extrapolation and to predict product performance
- Integrated clinical testing to optimize taste and pharmacokinetic performance
- Adaptive clinical manufacturing and product supply strategies for global pediatric trials