Integration of Rapid Clinical Assessments and Formulation Development to Accelerate Pediatric Drug Development

Developing drug products for pediatric patients can present 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 and method of administration, the safety profile, overall taste and palatability, the child’s age, weight and the treatment plan’s requirements. All these key factors must be balanced in order to develop a pediatric product that achieves clinical, regulatory and commercial success.

In this seminar we will share strategies and case studies illustrating how key challenges in pediatric product development can be overcome, allowing drug developers to get medicines to pediatric patients in need faster.

You will learn:

• How understanding the taste of your Active Pharmaceutical Ingredient (API) early in development can help determine your taste masking strategy and target product profile (TPP)
• How integrated clinical testing can be used to optimize pharmacokinetic (PK) performance of new pediatric drug products
• How PBPK modelling and simulation can be utilized for dose extrapolation and to predict product performance
• How adaptive clinical manufacturing and product supply strategies can get product to global pediatric trials faster