Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
Today’s topic is about the lackluster recruitment of US centers in recent CABP trials. We noticed that Eastern European (EE) centers, specifically from Ukraine, Bulgaria, and Serbia, contribute patients in large numbers, actually making these trials feasible. When sponsors and CROs needed to enroll CABP patients, they could not rely Continue reading CABP TRIAL ENROLLMENT – BUT NOT IN THE USA
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