Cheikh Diack

TL;DR: A model-based meta-analysis was conducted in humans and nonclinical species and mathematical formulae are presented that allow prediction of the ocular t½ for molecules of interest, successfully demonstrated in case studies of aflibercept, brolucizumab, and PEGylated Fabs, where the predicted t½ values are found to be in reasonable agreement with the experimental data available.

TL;DR: A Bayesian adaptive approach based on one binary response (occurrence of a DLE) and one continuous response (a measure of potential efficacy) per subject is described and evaluated, finding comparable performance to alternative approaches using efficacy and safety for dose‐finding.

TL;DR: D dose-escalation designs that incorporate both the dose-limiting events and dose- Limiting toxicities (DLTs) and indicative responses of efficacy into the procedure are introduced.

TL;DR: The new approach that includes Bayesian adaptive design in single ascending dose (SAD) trials conducted in healthy volunteers shows a very good performance in the estimation of MTD and in reducing the total number of healthy subjects.

TL;DR: Transplant-related factors remain the most important determinants of DGF, AR and SCR, and rejection treatment with depleting antibodies effectively prevented SCR in 6-month surveillance biopsies.