The STEP (Safety and Toxicity of Excipients for Paediatrics) database. Part 1-A need assessment study

Excipients that are commonly used in adult medicines have been associated with elevated toxicological risks and safety issues in children. However, the information available on their acceptability for paediatric age groups is sparse and distributed over various sources. Hence, European (Eu) and United States (US) Paediatric Formulation Initiatives (PFIs) are collaboratively creating a STEP database. Because the development of database is a costly and time consuming venture, it is important to capture the requirements from the potential users and identify at an early stage the content and features that will serve the specific needs so that they can incorporate into the databases as it is developed. Aim: To assess the need of STEP database, to determine the database content and structure that meets the needs of the potential users. Method: A global survey was conducted via EuPFI website and email invitations, targeting a representative cross section of industrial, regulatory, academic and clinical professionals, to capture the database requirements. Result: The survey revealed (1) the potential users of this database, (2) the excipients' toxicity and safety information needs, (3) the content and structure preferred for the database. Majority of respondents favoured the development of STEP database and reported that it would be a valuable resource. Conclusion and future work: The survey emphasized the need for STEP database and thus leads us to development of pilot database to assess the feasibility of developing such a database. (c) 2012 Elsevier B.V. All rights reserved.