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

Buckley, L; Salunke, S; Thompson, K; Baer, G; Fegley, D; Turner, M; (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. 10.1016/j.ijpharm.2017.07.042. Green open access

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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.

Type: Article
Title: Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ijpharm.2017.07.042
Publisher version: https://doi.org/10.1016/j.ijpharm.2017.07.042
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Excipients, Safety assessment, Pediatric, Formulation development
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics
URI: https://discovery.ucl.ac.uk/id/eprint/10046591
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