The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats. This paper is the second in a series that presents the update on the Safety and Toxicity of Excipients for Paediatrics ("STEP") database being developed by Eu-US PFIs, and describes the architecture data fields and functions of the database. The STEP database is a user designed resource that compiles the safety and toxicity data of excipients that is scattered over various sources and presents it in one freely accessible source. Currently, in the pilot database data from over 2000 references/10 excipients presenting preclinical, clinical, regulatory information and toxicological reviews, with references and source links. The STEP database allows searching "FOR" excipients and "BY" excipients. This dual nature of the STEP database, in which toxicity and safety information can be searched in both directions, makes it unique from existing sources. If the pilot is successful, the aim is to increase the number of excipients in the existing database so that a database large enough to be of practical research use will be available. It is anticipated that this source will prove to be a useful platform for data management and data exchange of excipient safety information.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ijpharm.2013.09.013 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
GX-188E DNA vaccine plus pembrolizumab in HPV 16- and/or 18-positive recurrent or advance cervical cancer: a phase 2 trial.
EClinicalMedicine
August 2024
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Background: In an interim analysis of this phase 2 trial, adding the GX-188E vaccine to pembrolizumab resulted in manageable toxicity with antitumor activities in patients with recurrent or advanced cervical cancer. Here, we report the final safety and efficacy results after a long-term follow-up at the study's completion.
Methods: This open-label, single-arm, phase II trial was conducted in nine hospitals in South Korea (ClinicalTrials.
Artificial food dyes are toxic: Neurobehavioral implications in children.
Brain Spine
July 2023
Center for Global Health Research, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences (SIMATS), Thandalam, Tamil Nadu, India.
Emerging research highlights the potential neurobehavioral impacts of synthetic food dyes on children, prompting a reevaluation of their safety and regulatory standards. This letter discusses recent findings that associate synthetic food dyes with adverse behavioral outcomes, such as hyperactivity, particularly in children with or without identified behavioral disorders. It calls for updated regulatory guidelines that reflect current research, advocating for protecting children's behavioral health.
View Article and Find Full Text PDFJapan's Growing Public Health Crisis: Tackling the Alarming Increase in Streptococcal Toxic Shock Syndrome.
Cureus
December 2024
Gastroenterology, School of Digestive and Liver Diseases, Institute of Postgraduate Medical Education and Research, Kolkata, IND.
Japan is experiencing a dramatic spike in streptococcal toxic shock syndrome (STSS) cases, exceeding the previous year's statistics. This life-threatening illness, caused by , has been connected not only to the relaxation of COVID-19 precautions but also to the prolonged effects of confinement and lack of contact with the surrounding environment/ecology. The condition is characterized by a sudden onset of symptoms, including high fever, rash, and shock, and demands immediate medical intervention.
View Article and Find Full Text PDFChimeric Antigen Receptor (CAR) T-cell Therapy in the Treatment of Diffuse Large B-cell Lymphoma (DLBCL): A Systematic Review.
Cureus
December 2024
Internal Medicine, California Institute of Behavioral Neurosciences and Psychology, Fairfield, USA.
Chimeric antigen receptor (CAR) T-cell therapy has shown very promising results in the treatment of refractory or relapsed diffuse large B-cell lymphoma (DLBCL). This systematic review evaluates the effectiveness and side effects of CAR T-cell therapies, focusing on factors affecting both clinical outcomes and adverse effects. This review included data from 14 studies involving 1392 patients with DLBCL who underwent CAR T-cell therapy.
View Article and Find Full Text PDFBosutinib for the Treatment of CML-Using it Safely: a Podcast.
Target Oncol
January 2025
Division of Hematology and SCT, Georgia Cancer Centre, Augusta, GA, USA.
Bosutinib is a second-generation tyrosine kinase inhibitor (TKI) approved for use in patients with newly diagnosed Philadelphia chromosome (Ph)-positive chronic phase (CP) chronic myeloid leukemia (CML), as well as Ph-positive CP, accelerated phase, or blast phase (with chemotherapy) CML resistant or intolerant to prior therapy. Clinical trials have shown bosutinib is effective as first-line therapy for patients with CML as well as in later lines of therapy after prior TKI failure. Bosutinib has an established safety profile; however, as with all TKIs approved for the treatment of CML, there are adverse events (AEs) that require management.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!