Publications by authors named "Rena J Eudy-Byrne"
Article Synopsis
- SGLT inhibitors, like empagliflozin, are used alongside insulin in type 1 diabetes to improve blood sugar levels, but they increase the risk of diabetic ketoacidosis.
- Two clinical trials, EASE-2 and EASE-3, tested empagliflozin, including a low 2.5-mg dose in EASE-3, which previously had established efficacy through higher doses.
- Researchers created two models, M-EASE-1 and M-EASE-2, to simulate and validate the effectiveness of the 2.5-mg dose using modeling techniques that can support drug efficacy assessments when trial data is limited.
Article Synopsis
- The study focused on evaluating the pharmacokinetic (PK) similarity between the biosimilar adalimumab-adbm and the original adalimumab (Humira) in patients with rheumatoid arthritis (RA).
- Researchers developed population pharmacokinetic (PPK) models using data from both healthy subjects and RA patients to analyze the effects of factors like weight and antibodies on drug clearance.
- Results demonstrated that adalimumab-adbm and Humira had similar PK profiles, supporting the idea that switching from Humira to adalimumab-adbm does not significantly impact drug clearance in RA patients.
Aim: To confirm the observed reduction in HbA1c for the 2.5 mg dose in EASE-3 by modelling and simulation analyses.
Materials And Methods: Independent of data from EASE-3 that tested 2.
A hazard model of fracture was developed using individual patient data (IPD) from the NHANES (2005-2008) database and summary-level data from an aggregate dataset (AD). The AD was built by performing a comprehensive and systematic literature search of clinical studies published from 1995 to 2015, recording fracture rate and bone mineral density (BMD) for both treatment and placebo arms. The search resulted in a metadata set comprised of 21 studies investigating the effects of various bisphosphonates, teriparatide, denosumab, and raloxifene in 65,254 patients over a cumulative 56.
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