Allphase Pharma Consulting, LLC
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There was not much for us to report on this summer that would interest our readership… Let’s skip the Fauci / Paul senate drama regarding the origins of Covid, with senator Paul taking the role of the Grand Inquisitor and Dr. Fauci the Fifth. The latest act in this screen Continue reading Avacopan / TAVNEOS Follow-Up
Language-related issues come up quite frequently. Most interactions with regulators are held in English, but not all of them. In China, it is Mandarin, and in Japan it is, well, Japanese. In Europe, it is mostly English, but French and German occasionally creeps into the dialogue. In China, even if Continue reading REGULATORY INTERACTIONS – 2 The “KATA” of Proper Behavior
We have often mentioned the central importance of microbiological response as an endpoint in trials of antibacterials. This is contrary to other therapeutic areas, in which the etiology is less understood and where surrogate markers are needed. In bacterial infectious diseases we have the luxury of knowing exactly what causes Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials