Literature DB >> 26117188

The STEP database through the end-users eyes--USABILITY STUDY.

Smita Salunke1, Catherine Tuleu2.   

Abstract

OBJECTIVES: The user-designed database of Safety and Toxicity of Excipients for Paediatrics ("STEP") is created to address the shared need of drug development community to access the relevant information of excipients effortlessly. Usability testing was performed to validate if the database satisfies the need of the end-users.
METHOD: Evaluation framework was developed to assess the usability. The participants performed scenario based tasks and provided feedback and post-session usability ratings. Failure Mode Effect Analysis (FMEA) was performed to prioritize the problems and improvements to the STEP database design and functionalities. RESULT: The study revealed several design vulnerabilities. Tasks such as limiting the results, running complex queries, location of data and registering to access the database were challenging. The three critical attributes identified to have impact on the usability of the STEP database included (1) content and presentation (2) the navigation and search features (3) potential end-users.
CONCLUSION: Evaluation framework proved to be an effective method for evaluating database effectiveness and user satisfaction. This study provides strong initial support for the usability of the STEP database. Recommendations would be incorporated into the refinement of the database to improve its usability and increase user participation towards the advancement of the database.
Copyright © 2015 Elsevier B.V. All rights reserved.

Entities:  

Keywords:  Additives; Adverse effects; Children; Excipients; Information resource; Neonates; Paediatrics; STEP database; Safety; Toxicity

Mesh:

Substances:

Year:  2015        PMID: 26117188     DOI: 10.1016/j.ijpharm.2015.06.016

Source DB:  PubMed          Journal:  Int J Pharm        ISSN: 0378-5173            Impact factor:   5.875


  6 in total

1.  Substitution as a Strategy to Improve Excipient Exposure in Neonates: One Piece of the Puzzle.

Authors:  Karel Allegaert; Isabel Spriet
Journal:  Paediatr Drugs       Date:  2016-06       Impact factor: 3.022

Review 2.  The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.

Authors:  Jumpei Saito; Anjali Agrawal; Vandana Patravale; Anjali Pandya; Samuel Orubu; Min Zhao; Gavin P Andrews; Caroline Petit-Turcotte; Hannah Landry; Alysha Croker; Hidefumi Nakamura; Akimasa Yamatani; Smita Salunke
Journal:  Children (Basel)       Date:  2022-03-23

3.  A retrospective and observational analysis of harmful excipients in medicines for hospitalised neonates in Latvia.

Authors:  Inese Sviestina; Dzintars Mozgis
Journal:  Eur J Hosp Pharm       Date:  2017-03-03

4.  Pediatric Safety of Polysorbates in Drug Formulations.

Authors:  Christina Kriegel; Matthias Festag; Ravuri S K Kishore; Dieter Roethlisberger; Georg Schmitt
Journal:  Children (Basel)       Date:  2019-12-20

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

Authors:  Lorrene A Buckley; Smita Salunke; Karen Thompson; Gerri Baer; Darren Fegley; Mark A Turner
Journal:  Int J Pharm       Date:  2017-07-17       Impact factor: 5.875

Review 6.  Excipients in the Paediatric Population: A Review.

Authors:  Khadija Rouaz; Blanca Chiclana-Rodríguez; Anna Nardi-Ricart; Marc Suñé-Pou; Dèbora Mercadé-Frutos; Josep María Suñé-Negre; Pilar Pérez-Lozano; Encarna García-Montoya
Journal:  Pharmaceutics       Date:  2021-03-13       Impact factor: 6.321

  6 in total

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