The Challenges And Opportunities Of Pediatric Dosage Form Development: Part 1 - Program Design And Formulation Development

By Nazim Kanji, Executive Director, Pediatric Services, Quotient Sciences

A combination of unmet patient needs, regulatory incentives and potential penalties has now driven a significant upturn in industrial research to develop new pediatric medicines.

Development scientists must consider the route of administration, the safety profile, overall taste and palatability, the child’s age, weight, physiological condition and the overall treatment plan. All of these key points must be balanced appropriately in order to successfully develop an acceptable pediatric product that achieves clinical, regulatory and commercial success. Arguably however, the greatest industry challenge remains a lack of clarity and guidance on how these development objectives can be successfully met.

In Part 1 of this two-part blog piece, Quotient’s Executive Director of Pediatric Services, Nazim Kanji, will cover key considerations in pediatric program design and formulation development strategies that sponsors should take into account if they want to successfully bridge from initial concept into later stages of development and through to commercialization.