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The STEP (safety and toxicity of excipients for paediatrics) database. Part 1-A need assessment study

Smita Salunke1, George Giacoia, Catherine Tuleu

  • 1Pharmaceutics and Centre for Paediatric, Pharmacy Research, UCL, School of Pharmacy, United Kingdom. Smita.Salunke@pharmacy.ac.uk

International Journal of Pharmaceutics
|May 16, 2012
PubMed

Insights

The STEP database is needed to consolidate information on excipient safety for pediatric medicines. A global survey confirmed user demand for this valuable resource, leading to pilot database development.

Area of Science:

  • Pharmaceutical Sciences
  • Toxicology
  • Regulatory Affairs

Background:

  • Commonly used excipients in adult medicines pose toxicological risks and safety concerns for children.
  • Information on excipient acceptability for pediatric populations is fragmented and scarce.
  • The European and United States Paediatric Formulation Initiatives (PFIs) are developing the STEP database to address this gap.

Purpose of the Study:

  • To assess the necessity and demand for the STEP database.
  • To define the optimal content and structural framework for the STEP database based on user needs.

Main Methods:

  • A global survey was distributed through the European Paediatric Formulation Initiative (EuPFI) website and email invitations.
  • The survey targeted a diverse group of professionals in industrial, regulatory, academic, and clinical fields.
  • Data collection focused on understanding user requirements for the STEP database.

Main Results:

  • The survey identified key potential users of the STEP database.
  • It elucidated specific information needs regarding excipient toxicity and safety for pediatric use.
  • Respondents overwhelmingly supported the STEP database development, deeming it a valuable resource and indicating preferred content and structure.

Conclusions:

  • The survey strongly emphasized the critical need for the STEP database.
  • Findings support the ongoing development of a pilot STEP database to evaluate feasibility and refine the approach.
Abstract

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