Executive Director - Drug Product Novo Nordisk Basking Ridge, New Jersey
The presentation will provide guidance in the appropriate risk assessment of excipients for pediatric products, highlight commonly encountered challenges in use of excipients in pediatric products along with considerations for mitigation of risks. A systematic benefit-risk assessment process called the “Paediatric Excipient Risk Assessment (PERA)” framework., which proposes a holistic approach considering all relevant factors related to patient, dosage form, and excipient will be presented to help formulators address the challenge of selecting excipients. An excipient selection PERA tool along with case studies will demonstrate how safe excipient selection dilemma can be resolved. Proper use of the PERA tool will lead to identification of any potential gaps in the information of excipients, which will assist the users to establish appropriate mitigation strategy or action plan with the cross-functional team for developing patient centric medicines. The future outlook consists of further establishing this tool as user prompted Artificial Intelligence interface linked to excipient databases to accelerate risk assessment and selection of excipients.
Learning Objectives:
Attendees will learn a new benefit/risk-based framework to select excipients for paediatrics by considering all relevant factors related to patient, dosage form, and excipient attributes.
Attendees will learn the usability of the risk assessment tool and a consistent approach in selecting excipients for development of global paediatric dosage form.
Attendees will learn how to identify any potential gaps in the information of excipients by utilizing PERA tool and establish appropriate mitigation strategy or action plan with the cross-functional team.
