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Month: March 2025

Gepotidacin ABSSSI – How to Fail Adaptively,

Posted on March 28, 2025 by Harald — No Comments ↓

Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment.  This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary endpoint was a non-standard composite efficacy and safety endpoint that Continue reading Gepotidacin ABSSSI – How to Fail Adaptively,→

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Posted in QIDP Antibiotics, Recent Literature, The News, The Viewpoint | Tagged ABSSSI, adaptive design, Allphase Pharma Consulting, antibiotic blog, Bluejepa, dose-finding, FDA approval, FDA endpoint criteria, Gepotidacin, GSK2140944, Harald Reinhart, MRSA resistance, uUTI | Leave a reply

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