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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 Continue reading Microbiological Response as Primary Efficacy Endpoint for Antibacterials
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 Continue reading REGULATORY INTERACTIONS – 1
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 Continue reading PK/PD of BIOLOGICALS
“Chance favors the prepared mind” is the short form of a statement by Louis Pasteur which actually reads: “In the fields of observation chance favours only the prepared mind” or ” Dans les champs de l’observation le hasard ne favorise Continue reading About A Prepared Mind – In R&D
It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x ’20 initiative got underway. Its goals were spelled out clearly: To ‘Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 ’[3]. It Continue reading The 10 x ’20 Initiative – A Retrospective