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

International Journal of Pharmaceutics
Smita SalunkeCatherine Tuleu

Abstract

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. To assess the need of STEP database, to determine the database content and structure that meets the needs of the potential users. 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. 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 respo...Continue Reading

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Citations

Nov 1, 2012·European Journal of Pediatrics·Catherine Tuleu, Joerg Breitkreutz
Jan 8, 2013·European Journal of Pediatrics·Karel Allegaert
Sep 22, 2015·International Journal of Molecular Sciences·Brandon J DixonJohn H Zhang
Dec 25, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·David P ElderRené Holm
Jun 29, 2015·International Journal of Pharmaceutics·Smita SalunkeUNKNOWN European Paediatric Formulation Initiative (EuPFI)
Sep 28, 2013·International Journal of Pharmaceutics·Smita SalunkeCatherine Tuleu
Nov 6, 2013·Advanced Drug Delivery Reviews·Hannah K BatchelorSandra Klein
Sep 16, 2014·Frontiers in Genetics·Daniel P SageGregory T Knipp
Jul 17, 2016·AAPS PharmSciTech·Smita SalunkeUNKNOWN European Paediatric Formulation Initiative (EuPFI)
Aug 6, 2016·International Journal of Pharmaceutics·A C WalchUNKNOWN EREMI Group
Sep 21, 2016·European Journal of Pediatrics·William Wei Lim Chin, Angelika Joos
Jul 22, 2017·International Journal of Pharmaceutics·Lorrene A BuckleyMark A Turner
Feb 8, 2013·World Journal of Clinical Pediatrics·Karel Allegaert
Aug 21, 2018·Pharmaceutical Development and Technology·V Merino-BohórquezUNKNOWN Pharmaceutical Technology Working Group and Pediatric Pharmacy Working Group of the Spanish Society of Hospital Pharmacy (SE
Jul 3, 2019·International Journal of Molecular Sciences·Monika TrofimiukKatarzyna Winnicka
Aug 22, 2017·Therapeutic Delivery·Chulhun ParkBeom-Jin Lee
May 17, 2017·Frontiers in Pediatrics·John Vincent MartinoLeah E Cahill
Apr 10, 2015·British Journal of Clinical Pharmacology·Hannah K Batchelor, John F Marriott
Aug 23, 2016·Molecular Informatics·Giuseppe Felice MangiatordiOrazio Nicolotti
Sep 4, 2018·Pharmaceutical Medicine·Kristine Svinning ValeurKarel Allegaert
Jun 4, 2019·European Journal of Hospital Pharmacy. Science and Practice·Lukáš ZahálkaPetr Solich
Jan 9, 2021·AAPS PharmSciTech·Monika LavanGregory Knipp
Nov 19, 2020·International Journal of General Medicine·Anteneh BelaynehFantahun Molla
Apr 4, 2021·Pharmaceutics·Khadija RouazEncarna García-Montoya
Apr 21, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·David Cheng Thiam TanArzu Selen

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