Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients



Buckley, Lorrene A, Salunke, Smita, Thompson, Karen, Baer, Gerri, Fegley, Darren and Turner, Mark A ORCID: 0000-0002-5299-8656
(2018) Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 536 (2). pp. 563-569.

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Abstract

A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement.

Item Type: Article
Uncontrolled Keywords: Excipients, Safety assessment, Pediatric, Formulation development
Depositing User: Symplectic Admin
Date Deposited: 24 Oct 2017 08:41
Last Modified: 19 Jan 2023 06:52
DOI: 10.1016/j.ijpharm.2017.07.042
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3010759