Salunke, S; (2017) Development and Evaluation of Database of Safety and Toxicity of Excipients for Paediatrics (STEP database). Doctoral thesis , UCL (University College London).

Abstract

The screening and careful selection of excipients is a critical step in paediatric formulation development, as excipients that are commonly used in adult medicines have been associated with elevated toxicological risks and safety issues in children. An evidence-based approach of toxicity assessment of excipients with the least possible amount of testing is the way forward to addressing the issues with excipients in paediatrics. However, the information available on their safety in paediatric age groups is sparse and distributed over various sources Aim: To design and implement the Safety and Toxicity of Excipients for Paediatrics (“STEP”) database for quick and reliable access of the safety information of excipient to facilitate paediatric product development. Method: Three-phase framework was developed. Phase 1: The need assessment study was conducted with potential users through a global survey reporting their information needs and interest in the STEP database. Phase 2: The potential users input was employed for designing the STEP database and developing methodologies to retrieve, evaluate and extract the information into the database. Phase 3: Evaluation framework was developed to evaluate the usability of the STEP database. Result: The survey emphasized the need for STEP database. 90% of respondents reported owning the STEP database. The survey helped in identifying needs and potential obstacles in developing the database. In response, the database that provides easy access to the safety and toxicity data of excipients was developed. The methodology adopted provides an in-depth retrieval and evaluation of the safety and toxicity data of excipients. Usability testing revealed design vulnerabilities, and the system was adapted to address the user’s needs and preferences accordingly. Conclusions and Implications for Practice: Through a comprehensive development process including user surveys, the freely accessible STEP database was launched. It is used successfully with more than 2500 users.

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