Publications by authors named "Anne Sofie Osterdal"
Article Synopsis
- The study focuses on the effectiveness of a sublingual immunotherapy (SLIT) tablet for treating house dust mite-induced allergic rhinitis in children aged 5-11 years, addressing a gap in existing data for this age group.
- Conducted as a Phase III randomized trial, 1460 children were divided into two groups: one receiving the SLIT tablet and the other receiving a placebo, with significant improvements observed in allergy symptoms and quality of life for the SLIT group.
- Results showed a notable 22% reduction in the total combined rhinitis score for the SLIT group compared to placebo, alongside improved scores in other related outcome measures, suggesting SLIT's potential as an effective
Background: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced predefined quality tolerance limits (QTLs) as a quality control in clinical trials. QTLs are complementary to Quality by Design (QbD) principles (ICH-E8) and are one of the components of the risk-based clinical trial quality management system.
Methods: Currently the framework for QTLs process is well established, extensively describing the operational aspects of Defining, Monitoring and Reporting, but a single source of commonly used methods to establish QTLs and secondary limits is lacking.