The pharmaceutical excipients working group aims to address safety issues and problems associated with the excipients likely to be used in paediatric formulations. The group is intended to drive forward the development of the methodological approaches for conducting a high-level scientific literature review to retrieve and evaluate the safety and toxicity information of excipients for children. The group will determine a prioritization process for selected excipients based on: the strength of the literature evidence; broad applicability across the pharmaceutical industry; and potential for endorsement in Europe, US and worldwide following regulatory screening.
Develop STEP Database : The group has performed a global survey to assess the need of this excipients database and further develop a prototype database based on the user’s needs. The long term goals are to implement this prototype database with several high priority excipients, to collect initial feedbacks from users for refinement, eventually include more excipients and maintain the finalized database.
INTERACTIONS WITH THE WORK CARRIED OUT BY OTHER GROUPS
In carrying out its mandate, the excipients working group are working closely with United States Formulation Initiative (US PFI) excipients working group, to examine the risks of excipients in paediatrics, to identify gaps in safety information, and ultimately create and maintain a STEP database that is available to drug sponsors, scientists and the public.
It is envisaged that the first prototype version of STEP database will be available to users by early next year 2013. The beta version is available on request.