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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
Sometimes we come across an article we wish we had read earlier. This was the case with the publication by Zhao and colleagues[1]. The article, now more than 12 years old, was written in the ‘early’ days of biological drug development, after the first wave of mAbs had already been Continue reading PK/PD of BIOLOGICALS