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Gepotidacin Study 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 Continue reading Gepotidacin ABSSSI – How to Fail Adaptively
Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
While the news is abuzz with reports of Zika virus coming to a place near you, an interesting article on a much more mundane topic – the treatment of uncomplicated UTIs – should be competing for your attention. It is a publication we Continue reading Ibuprofen for uUTI (Part 2): Antibiotic or NSAID? Or Both? Or Neither?
At the recent AMDAC, the frequent mention of an unusual uUTI study caught my attention. In their review of placebo-controlled trials, FDA mentioned a study comparing ciprofloxacin with Ibuprofen (Motrin), an NSAID drug without any antibacterial activity[1]. By the outcome Continue reading Ibuprofen For uUTI: Interesting Pilot Trial But More to Come Soon
Any FDA meeting is a high-stakes game for industry: One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective. At other times, simple issues seem to create Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?