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Microbiological Response as Primary Efficacy Endpoint for Antibacterials

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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→

REGULATORY INTERACTIONS  – 1

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It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators.  There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS  – 1→

PK/PD of BIOLOGICALS

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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→